2ADD7DYN380601CODEVFreedom Flow II

1 DYNALLOY, Inc. Makers of Dynamic Alloys DYNALLOY, Inc. Makers of Dynamic Alloys FLEXINOL® FLEXINOL® User Manual If used properly, this device will enhance your independence and will provide you with years of trouble free usage. The advantages offered by Freedom Flow™ II include: • Independence from a wheelchair battery, enabling you to use the device on powered or manual wheelchairs. • Ease of installation on your leg bag and wheelchair. • Touch-sensitive operation that empties your leg bag. • Usage for more than one week on a single overnight charge. • Light weight and small size without bulky appearance. • Silent operation without clicking or buzzing noises. • Substantially reduced risk of urinary tract infection since no part of the device makes direct contact with urine. • Possibility of back-up manual operation if the device unexpectedly runs out of charge. • Highly secure wireless remote control avoids tangling of wires in wheel and simplifies movements. F5015Rev A.4 1 FCC Statement 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. Any changes made to the circuitry or design aspects of this device will void it’s FCC verification. INSTRUCTION TO THE USER This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: * Reorient or relocate the receiving antenna. * Increase the separation between the equipment and receiver. * Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. * Consult the dealer or an experienced radio/TV technician for help. In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment. 8 2 Parts List 1. Main Unit 2. Remote Switch 3. Charger Base 4. Universal charger 5. Car Charger 6. Latex Tubing 2 Notes: The latex tube size and softness degree are important for proper operation of the Freedom Flow™ II device. We suggest you to keep a small section of the supplied latex tube for reference when purchasing new tubes. You should clean the supplied tube prior to the first and after each use daily with cleaning solutions recommended for your urological appliances. To disconnect the device from the leg bag simply press the manual release button while holding the device as shown. Next pull the rubber tubing outward. Clean the device by wiping it with a dampened cloth. To secure the switch from loss by accidental detachment we recommend fastening its metallic ring to the wheelchair with a strong string. Limited 1 Year Warranty Freedom Flow™ II is warranted against defects in material or workmanship for 1 year from date of purchase. Any problem arising from misuse, attempts at repair, dropping, excessive contact with water, or extreme wear are not covered by this warranty. If your Freedom Flow™ II fails to function during this 1 year period, we will repair or replace your unit free of charge. Only UPS Ground Shipping will be provided by Dynalloy, Inc. Dynalloy, Inc. 1562 Reynolds Ave., Irvine, CA 92614 Phone: 714-436-1206 Fax: 714-436-1213 www.dynalloy.com 3 DYNALLOY, Inc. Makers of Dynamic Alloys DYNALLOY, Inc. Makers of Dynamic Alloys FLEXINOL® FLEXINOL® Congratulations! You have just purchased the ultimate leg bag emptier... the Freedom Flow™ II device. Operation The Freedom Flow™ II pinch mechanism opens and closes slowly. When holding the Freedom Flow™ II switch “On” allow 3-4 seconds for the pinch mechanism to open. After releasing the switch allow 3-4 seconds for the clamp mechanism to close. The clamp only opens slightly, which is sufficient for rapid emptying. THIS IS THE NORMAL OPERATION OF FREEDOM FLOW™ II. We suggest you to first install Freedom Flow™ II on a new bag filled with tap water and observe Freedom Flow™ II work over a sink to familiarize yourself with its operation. Freedom Flow™ II operates by sliding onto your leg bag latex tubing and pinching the tube closed. When activated, Freedom Flow™ II will open and allow the urine to drain. When deactivated, it will re-pinch the tube. Freedom Flow™ II uses innovative technology that makes our safe and reliable design possible. 3 Charging the Freedom Flow™ II: 1. Plug the Main Unit into the Charger Base. 2. Plug the Universal Charger or the Car Charger into the Charger Base. 3. Plug the Universal Charger into a household outlet. If using the Car Charger, plug the Car Charger into the car outlet. • Note: The LED on both Universal or Car Charger and the Charger Base will turn red. This indicates charging status. • When the unit is fully charged (will take a few hours), the LED on the Charger Base will turn green. Now the unit is ready for use. • The transmitter battery in the Remote Switch should work for over a year before needing replacement. • One overnight charge should be sufficient for one …

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10/13/2014 CETCB 114 Olinda Drive Brea, CA 92823 Gentlemen: This is a letter of authorization to accept Compatible Electronics, Inc., specifically including the employees of Compatible Electronics, as an Agent for Concept Development Group (CDG) located at 7 Almond Tree Lane, Irvine CA 92612, for a period of one year, to sign applications before the Commission on our behalf, to make representations to you on our behalf, and to receive and exchange data between our company and the Commission in connection with certification of the following Concept Development Group/Dynalloy, Inc. product: A Wireless Urine Leg Bag Emptier for Physically Disabled Individuals which includes a remote control system consisting of a transmitters, a receiver and a battery charger; under FCC Docket Number 20780 and General Docket Number 80-284 pursuant to Part l5 of FCC Rules and Regulations. Please also accept this letter as an attestation that neither Concept Development Group nor any of its officers, directors, or persons holding 5% or more of the outstanding stock or shares, voting or non-voting, have been denied federal benefits under section 5301 of the Anti-Drug-Abuse act of 1988, 21 U.S.C. 853(a). In addition, Concept Development Group will notify the Federal Communications Commission if, at any time, the situation changes causing Concept Development Group to be denied federal benefits. If you have any further questions or need additional information, please feel free to give me a call at (714) 642-1853 or (949) 734-5081. Sincerely, M. T. Fatehi, Ph.D. (EE) Director of R&D Concept Development Group

1 10/13/2014 Compatible Electronics TCB 114 Olinda Drive Brea, California 92823 Subject: TCB application submittal Gentlemen: We, Concept Development Group, would like to declare that the application being submitted for the device with FCC ID: 2ADD7DYN380601CODEV, has not been submitted to another TCB or FCC for certification. If you have any questions, please do not hesitate to contact us at (714) 642-1853 Sincerely, M. T. Fatehi, Ph.D. (EE) Director of R&D Concept Development Group

02/25/2015 Compatible Electronics TCB 114 Olinda Drive Brea, California 92823 Subject: Modification Letter for FCC ID: 2ADD7DYN380601CODEV Gentlemen: This letter is to formally notify you tha the following modification has been completed by Compatible Electronics, Inc. to our Freedom Flow II during FCC certification, and will be implemented in production. Modification: Change R6 to 470 ohms. Sincerely, M. T. Fatehi, Ph.D. (EE) Director of R&D Concept Development Group 2 Note: Normally schematics, detailed block diagrams, and detailed theories of operation are the only information held confidential. Internal photographs are only held confidential in certain circumstances where the access to the information isn’t available to the end user. Test reports, cover letters, external photos, ID labels, setup photos, attestation statements, and RF exposure reports will not be held confidential.

1 10/13/2014 Compatible Electronics TCB 114 Olinda Drive Brea, California 92823 Subject: Request for withholding from public disclosure the schematics, block diagrams, and operational description pursuant to an application for certification Gentlemen: We, Concept Development Group, would like to request that all schematics, block diagrams, and operational descriptions submitted with the application for certification be withheld from public disclosure as per Section 0.459 of FCC Rules. This request is made under the provisions of Section 0.457 (d) of the Commission’s Rules, and Section 552 (b)(4) of the Freedom of Information Act. These sections authorize the withholding from public inspection, those materials which would be privileged as a matter of law if retained by the person submitting them, and materials which would not customarily be released to the public by that person. If you have any questions, please do not hesitate to contact us at (714) 642-1853 or (949) 734-5081. Sincerely, M. T. Fatehi, Ph.D. (EE) Director of R&D Concept Development Group 2 Note: Normally schematics, detailed block diagrams, and detailed theories of operation are the only information held confidential. Internal photographs are only held confidential in certain circumstances where the access to the information isn’t available to the end user. Test reports, cover letters, external photos, ID labels, setup photos, attestation statements, and RF exposure reports will not be held confidential.

Correspondence by Project Project Number: Correspondence NumberMemo 2ADD7DYN380601CODEV-1 In order for processing of this certification application (FCC ID: 2ADD7DYN380601CODEV) to continue, the following issue(s) will have to be addressed: 1) Please provide a modification attestation letter. Response: The modification letter has been uploaded. Untitled Documenthttp://www.celectronics.com/CorrespondenceByProject.asp?ProjectNum... 1 of 12/26/2015 7:46 AM

FCC ID: 2ADD7DYN380601CODEV 1.35” 0.1” Sketch of FCC Label LocaDon Located on the circuit side of the remote control.

SAR Exclusion Justification This device FCC ID: is excluded from SAR testing by the following justification The maximum power that the transmitter is capable of is 0.07 mW Using the following formula from section 4.3.1 of KDB 447498 at test separation distances ≤ 50 mm [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] * [ √ f(GHz)] Duty Cycle 11.00% V alue 1-g (mW) 10-g (mW) 0.01 98 439 "Value" is  3 , the SAR test exclusion threshold 1-g power limit 10-g power limit 228 569 “source-based” time-averaging based on an inherent property or duty-cycle of a device is allowed. An example of this is the determination of exposure from a device that uses digital technology such as a time-division multiple-access (TDMA) scheme for transmission < 50mm power limits for above caclulation using specified frequency 2ADD7DYN380601CODEV Max Peak Power (dBm) Min Separation distance (mm) Frequency (Ghz) When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion. 0.43392 5 -11.62 SAREXJUST-B-0-43 REV A 01/21/2014

Report Number: B41009D1 FCC Part 15 Subpart B and FCC Section 15.231 Test Report Freedom Flow II Model: WUS1 Brea Division 114 Olinda Drive Brea, CA 92823 (714) 579-0500 Agoura Division 2337 Troutdale Drive Agoura, CA 91301 (818) 597-0600 Silverado Division 19121 El Toro Road Silverado, CA 92676 (949) 589-0700 Lake Forest Division 20621 Pascal Way Lake Forest, CA 92630 (949) 587-0400 Page 1 of 14 FCC PART 15, SUBPART B and C TEST REPORT for FREEDOM FLOW II Model: WUS1 Prepared for DYNALLOY, INC. 1562 REYNOLDS AVE. IRVINE, CA 92614 Prepared by:_____________________ KENNETH LEE Approved by:____________________ JAMES ROSS COMPATIBLE ELECTRONICS INC. 114 OLINDA DRIVE BREA, CALIFORNIA 92823 (714) 579-0500 DATE: OCTOBER 17, 2014 REPORT APPENDICES TOTAL BODY A B C D E PAGES 14 2 2 2 10 11 41 This report shall not be reproduced except in full, without the written approval of Compatible Electronics. Report Number: B41009D1 FCC Part 15 Subpart B and FCC Section 15.231 Test Report Freedom Flow II Model: WUS1 Brea Division 114 Olinda Drive Brea, CA 92823 (714) 579-0500 Agoura Division 2337 Troutdale Drive Agoura, CA 91301 (818) 597-0600 Silverado Division 19121 El Toro Road Silverado, CA 92676 (949) 589-0700 Lake Forest Division 20621 Pascal Way Lake Forest, CA 92630 (949) 587-0400 Page 2 of 14 TABLE OF CONTENTS Section / Title PAGE GENERAL REPORT SUMMARY 4 SUMMARY OF TEST RESULTS 5 1. PURPOSE 6 2. ADMINISTRATIVE DATA 7 2.1 Location of Testing 7 2.2 Traceability Statement 7 2.3 Cognizant Personnel 7 2.4 Date Test Sample was Received 7 2.5 Disposition of the Test Sample 7 2.6 Abbreviations and Acronyms 7 3. APPLICABLE DOCUMENTS 8 4. DESCRIPTION OF TEST CONGIFURATION 9 4.1 Description of Test Configuration - Emissions 9 5. LISTS OF EUT, ACCESSORIES AND TEST EQUIPMENT 10 5.1 EUT and Accessory List 10 6. TEST SITE DESCRIPTION 11 6.1 Test Facility Description 11 6.2 EUT Mounting, Bonding and Grounding 11 7. TEST PROCEDURES 12 7.1.1 Radiated Emissions (Spurious and Harmonics) Test – Lab D 12 7.1.2 RF Emissions Test Results 13 7.1.3 Bandwidth of the Fundamental 13 8. CONCLUSIONS 14 Report Number: B41009D1 FCC Part 15 Subpart B and FCC Section 15.231 Test Report Freedom Flow II Model: WUS1 Brea Division 114 Olinda Drive Brea, CA 92823 (714) 579-0500 Agoura Division 2337 Troutdale Drive Agoura, CA 91301 (818) 597-0600 Silverado Division 19121 El Toro Road Silverado, CA 92676 (949) 589-0700 Lake Forest Division 20621 Pascal Way Lake Forest, CA 92630 (949) 587-0400 Page 3 of 14 LIST OF APPENDICES APPENDIX TITLE A Laboratory Accreditations and Recognitions B Modifications to the EUT C Additional Models Covered Under This Report D Diagrams and Charts  Test Setup Diagrams  Antenna and Effective Gain Factors E Data Sheets LIST OF FIGURES FIGURE TITLE 1 Plot Map And Layout of Radiated Site 2 Layout of the Semi-Anechoic Test Chamber Report Number: B41009D1 FCC Part 15 Subpart B and FCC Section 15.231 Test Report Freedom Flow II Model: WUS1 Brea Division 114 Olinda Drive Brea, CA 92823 (714) 579-0500 Agoura Division 2337 Troutdale Drive Agoura, CA 91301 (818) 597-0600 Silverado Division 19121 El Toro Road Silverado, CA 92676 (949) 589-0700 Lake Forest Division 20621 Pascal Way Lake Forest, CA 92630 (949) 587-0400 Page 4 of 14 GENERAL REPORT SUMMARY This electromagnetic emission test report is generated by Compatible Electronics Inc., which is an independent testing and consulting firm. The test report is based on testing performed by Compatible Electronics personnel according to the measurement procedures described in the test specifications given below and in the "Test Procedures" section of this report. The measurement data and conclusions appearing herein relate only to the sample tested and this report may not be reproduced without the written permission of Compatible Electronics, unless done so in full. This report must not be used to claim product certification, approval or endorsement by NVLAP, NIST or any agency of the federal government. Device Tested: Freedom Flow II Model: WUS1 S/N: N/A Product Description: See Expository Statement. Modifications: The EUT was modified in order to comply with specifications. Please see the list of modifications in Appendix B. Customer: Dynalloy, Inc. 1562 Reynolds Ave. Irvine, CA 92614 Test Dates: October 9 and 16, 2014 Test Specifications: Emissions requirements CFR Title 47, Part 15, Subpart B; and Subpart C, sections 15.205, 15.209, and 15.231 Test Procedure: ANSI C63.4 Test Deviations: The test procedure was not deviated from during the testing. Report Number: B41009D1 FCC Part 15 Subpart B and FCC Section 15.231 Test Report Freedom Flow II Model: WUS1 Brea Division 114 Olinda Drive Brea, CA 92823 (714) 579-0500 Agoura Division 2337 Troutdale Drive Agoura, CA 91301 (818) 597-0600 Silverado Division 19121 El Toro Road Silverado, CA 92676 (949) 589-0700 Lake Forest Division 20621 Pascal Way Lake Forest, CA 92630 (949) 587-0400 Page 5 of 14 SUMMARY OF TEST RESULTS TEST DESCRIPTION RESULTS 1 Spurious Radiated RF Emissions, 10 kHz – 4.3392 GHz (Transmitter and Digital portion) The EUT complies with the Class B limits of CFR Title 47, Part 15 Subpart B; and the limits of CFR Title 47, Part 15, Subpart C, section 15.205, 15.209 and 15.231 2 Conducted RF Emissions, 150 kHz to 30 MHz This test was not performed because the EUT operates on battery power and does not connect to the AC mains. 3 -20 dB Bandwidth of the Fundamental The EUT complies with the limits of CFR Title 47, Part 15, Subpart C, section 15.231 [c]. Report Number: B41009D1 FCC Part 15 Subpart B and FCC Section 15.231 Test Report Freedom Flow II Model: WUS1 Brea Division 114 Olinda Drive Brea, CA 92823 (714) 579-0500 Agoura Division 2337 Troutdale Drive Agoura, CA 91301 (818) 597-0600 Silverado Division 19121 El Toro Road Silverado, CA 92676 (949) 589-0700 Lake Forest Division 20621 Pascal Way Lake Forest, CA 92630 (949) 587-0400 Page 6 of 14 1. PURPOSE This document is a qualification test report based on the e…

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Total Pulse Time with Blanking Interval is 10.87 ms Maximum Voltage 494 Volts Time of Pulse 1 = 103.80 us Time of Pulse 2 = 103.4 us Time of Pulse 3= 813.4 us Time of Pulse 4 = 223 us Time of Pulse 5 = 111.2 us Time of Pulse 6 = 152.5 us Time of Pulse 7 = 258.1 us Time of Pulse 8 = 109.3 us Time of Pulse 9 = 109.3 us Tim e of Pulse 10 = 153.5 us Time of Pulse 11 = 109.5 u s Time of Pulse 12 = 328.3 us Tim e of Pulse 13 = 109.3 us Tim e of Pulse 14 = 153.5 us Tim e of Pulse 15 = 1026 us Tim e of Pulse 16 = 109.3 us Tim e of Pulse 17 = 328.5 us Tim e of Pulse 18 = 149.5 us Tim e of Pulse 19 = 824.5 us DUTY CYCLE INFORMATION CONCEPT DEVELOPMENT GROUP FREEDOM FLOW II – TRANSMITTER MODE L: WUS1 PULSE NUMBER Time (uS) 1103.8 2103.4 3813.4 4223 5111.2 6152.5 7258.1 8109.3 9109.3 10153.5 11109.5 12328.3 13109.3 14153.5 151026 16109.3 17328.5 18149.5 19824.5 To tal On Time = 5,275.9 uS Total Time of Pulse with Blanking Interval = 10,870 uS Total Duty Cycle = 48.54 %