KXU-FMFSZ24Code Alert CA630

CA630 System In-Service Manual PN 0510-1116-A Released 04/15/13 Users must read this Guide before using the Product. 3125 North 126th Street, Brookfield, WI 53005 Phone: 800.669.9946 Web: www.rtf.com Copyright 2013 by RF Technologies, Inc. All Rights Reserved. No Part of this work may be reproduced or copied in any form or by any means without written permission from RF Technologies, Inc. Classifications The following information can be found on the back label of the CA630 control unit. Do not immerse in water Attention: Consult accompanying documents Type BF Device Direct Current RF Symbol Important Warnings It is important for your facility to implement and enforce the following WARNINGS in order to keep all equipment functioning properly. Disregarding the information and instructions in this document is considered abnormal use and may result in injury or system failure. WARNING ACCESSORIES (SUPPLIES)—To ensure patient safety and proper operation of equipment, use only parts and accessories manufactured or recommended by RF Technologies, Inc. Parts and accessories not manufactured or recommended by RF Technologies, Inc. may not meet the requirements of the applicable safety and performance standards. Failure to use the components and supplies specified by RF Technologies, Inc. may result in equipment and/or system failure. WARNING EXPLOSION HAZARD—This device should not be used in the presence of flammable gas mixtures. It should also not be used in oxygen enriched atmospheres. WARNING CHANGES OR MODIFICATIONS TO PRODUCT—RF Technologies prohibits changes or modifications to the product; this may void the user’s authority to oper- ate the equipment (FCC Code of Federal Regulations Title 47 Part 15.21). WARNING HIGH RISK FOR FALL—The CA630 System may not be suitable for patients who are at “HIGH RISK FOR FALL.” Other monitoring measures may also be required. The Fall Management System should not be a substitute for routine visual monitoring protocol by caregiving personnel. WARNING INSTALLATION AND CONFIGURATION—It is the responsibility of the facility to follow the installation instructions carefully, as outlined in the current Series Software Administrator Guide, and to use the components and supplies specified by RF Technologies, Inc. for all installations. Failure to use the components and supplies specified by RF Technologies, Inc. may result in equipment and/or system failure. WARNING INSTRUCTIONS FOR SET UP AND USE—It is the responsibility of the facility to follow the instructions for set up and use carefully, as outlined in this manual, and to use the components and supplies specified by RF Technologies, Inc. for set up and use. Do not attempt to use extension cords or other equipment not supplied by RF Technologies, Inc. Failure to use the components and supplies specified by RF Technologies, Inc. may result in equipment and/or system failure. WARNING PATIENT GENERATED ALARMS—Do not rely exclusively on patient generated alarms for patient care and safety. The alarm function of equipment in the possession of patients must be verified periodically and regular patient surveillance is recommended. WARNING PATIENT MONITORING—The most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. It is the responsibility of the facility to periodically check on patients in possession of RF Technologies, Inc.'s equipment (i.e. Pendants, Pull Cords, Control Units) to mitigate risk of inappropriate use of equipment or strangulation and stumbling hazards from cables and cords WARNING PRODUCT WARRANTIES—Failure to follow the Warnings and Cautions in this guide voids any and all Product Warranties WARNING STATIC DISCHARGE—Do not touch the conductor portion of any conductor or port. Damage to the device may result. WARNING STRANGULATIONS AND TRIPPING HAZARD—Due to the possibility of strangulation, all cables and cords should be routed away from the patient’s throat. Cables and cords must be routed in a way to prevent tripping hazards. WARNING SYSTEM INSPECTION—It is the responsibility of the facility to establish and facilitate a regular inspection schedule for your system. RF Technologies, Inc. recommends quarterly inspections of your system for safety and performance by a qualified RF Technologies, Inc. representative. To arrange for a quarterly inspection by RF Technologies, Inc., call our Technical Support Department at (800)-669-9946 or (262) 790-1771. Failure to provide regular inspection of these products may result in equipment and/or system failure. WARNING SYSTEM MAINTENANCE AND TESTING—It is the responsibility of the facility to establish and facilitate a regular maintenance schedule for your system, as outlined in the current Series Software Administrator Guide. This includes regular inspection, testing, and cleaning. RF Technologies, Inc. recommends monthly maintenance and testing of your system. It is also recommended that your facility keep records of maintenance and test completions. Failure to provide regular maintenance and testing of these products may result in equipment and/or system failure. WARNING SYSTEM WIRING—All permanent supply connections must be done in accordance with National Electric Code, NFPA 70. WARNING USER TRAINING—Only users who have received adequate training on the use of the system, as outlined in this manual, should use the system. It is the responsibility of the facility to ensure all users have been trained. Failure to adequately train employees may cause system failure due to user error. In addition, incorrect use of the equipment may also result in system failure. WARNING WORN OR DAMAGED PARTS—If the control unit pads or cables are worn or damaged, you must have the product serviced. For more information, see the section entitled “Service and Return.” WARNING All RF Technologies transmitters, pendants and banding material “PRODUCT” have been determined to be MR Unsafe as defined by AST…

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FCC ID: KXU-FMFSZ24 D.L.S. ELECTRONIC SYSTEMS, INC. 166 South Carter Street Genoa City, WI 53128 April 19, 2013 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Gentlemen: We are submitting for RF Technologies, Inc., a Code Alert CA630, Model Number: 0800-0491, with an FCC ID: KXU-FMFSZ24 for Certification. This unit has been tested and complies to Part 15, Subpart C. If there are any questions in regard to this application, please call D.L.S. Electronic Systems, Inc. at (262) 279-0210. Enclosed you will find a copy of our test report with the information and results of tests that is required under Part 15, Section 15.247. Thank you for your assistance in this matter. Sincerely, William M. Stumpf DLS/js

RFTSEHNE Lr¡E rts'* 3125 N. 126tn St. Brookfield, Wl 53005 1 -800-669-9946 Ph: 262-7 90-177 1 Fx:[email protected] www.rft.com LETTER OF AUTHORIZATION FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Ladies and or Gentlemen: I appoint Bill Stumpf or Arnom C. Rowe to act as agent in the preparation of applications under Part 15 of the Rules and Regulations of the Federal Communications Commission. I certify that the exhibits properly describe the device being submitted under this application and will implement any changes described in the test report. The following statement is required by the Federal Communications Commission: By checking yes, the applicant certifies that, in the case of an individual applicant, he or she is not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti- Drug Abuse Act of 1988, 21 U.S.C. 853(a), or, in the case of an non-individual applicant (e.g. corporation, partnership or other unincorporated association), no party to the application is subject to a denial of federal benefits, that includes FCC benef,rts, pursuant to that section. X YES NO r c ì\l \ ì-- T- C\ 20\-3 Dated this day of Agency agreement expiration date: None 6^^'\\4 \ srr &q-\\øt Signature Printed Di r¿cko r - Qu-\dv á ßnq\þqterephone By Title J/ Applicant ç o CS Ça 373"5 \\ R

166 South Carter Street, Genoa City, WI 53128 Request for Confidentiality Date: April 19, 2013 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: KXU-FMFSZ24 Pursuant to 47 CFR Section 0.459 RF Technologies, Inc. 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: • Block Diagram • Schematics • Description of Operation 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. RF Technologies, Inc. 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 William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

External Photos RF Technologies, Inc. Code Alert CA630 Model 0800-0491 Front - with Rubber Boot Front - with Rubber Boot removed Back - with Rubber Boot Back - with Rubber Boot removed Bottom - showing Ports

Artwork 0700-0221-B Label 0150-0852 Created in Adobe Illustrator 10 All Type Black unless otherwise noted Do Not Print Black Box Arial 6pt. Arial 5pt. Intertek ETL Listed C Us.ai IEC417-5333-878-02-03.tif Arial 10pt. Arial 7pt. Arial 6pt. Warning.tif 64.6% IEC417-5031.tif 100% Keep dry.tif CodeAlert logo.ai Arial 6pt. Arial 6pt. Arial 8pt. 1-800-669-9946 Use Only Power Supply PN 0180-0025 Sensor Jack Nurse Call Jack AC Jack 9 VDC RF Technologies, Inc. 3125 North 126th Street, Brookfield, WI 53005 USA www.rft.com M/N: 0800-0491 FCC ID: KXU-FMFSZ24 IC: 2719A-FMFSZ24 CAN ICES-3(B)/NMB-3(B) RF Symbol.jpg 3048736 Medical Electrical Equipment 1-800-669-9946 Use Only Power Supply PN 0180-0025 Sensor JackNurse Call Jack AC Jack 9 VDC RF Technologies, Inc. 3125 North 126th Street, Brookfield, WI 53005 USA www.rft.com M/N: 0800-0491 FCC ID: KXU-FMFSZ24 IC: 2719A-FMFSZ24 CAN ICES-3(B)/NMB-3(B) 3048736 Medical Electrical Equipment RF Technologies, Inc. Code Alert CA630 Model 0800-0491 Label Placement to show location. Final label information documented above. Size: 2" x 2-3/8"

Internal Photos RF Technologies, Inc. Code Alert CA630 Model 0800-0491 Battery Cover Removed Battery Removed Back Cover Removed Inside Covers Circuit Board - Side 1 Circuit Board - Side 1 with Buzzer Removed Circuit Board - Side 2

RF Exposure Compliance Company: RF Technologies, Incorporated Model: 0800-0491 Formal Name: Code Alert CA630 Rule Part: CFR 47 Part 1.1307(b) CFR 47 Part 2.1093 Test Procedure: FCC 447498 10 D01 General RF Exposure Guidance v05 4.3. General SAR test reduction and exclusion guidance 4.3.1. Standalone SAR test exclusion considerations Limits: The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)]· [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where: f(GHz) is the RF channel transmit frequency in GHz. Power and distance are rounded to the nearest mW and mm before calculation. The result is rounded to one decimal place for comparison. When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. Output Power: This is a portable device. The maximum peak conducted output power measured 7.20 dBm. The antenna gain is 2.1 dBi. effective isotropic radiated power (e.i.r.p.) = 7.20 dBm + 2.1 dBi = 9.30 dBm = 8.51 mW Exclusion threshold: [9 mW / 5 mm] x [√2.405 GHz] = 2.8 Results: 2.8 is ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR. SAR measurement is not necessary.

166 South Carter, Genoa City, WI 53128 Page 1 of 66 Company: RF Technologies, Inc. Model Tested: 0800-0491 Report Number: 18925 DLS Project: 5788 i. Cover Page Code of Federal Regulations 47 Part 15 – Radio Frequency Devices Subpart C – Intentional Radiators Section 15.247 Operation within the bands 902 - 928 MHz, 2400 - 2483.5 MHz, 5725 - 5875 MHz, and 24.0 - 24.25 GHz. THE FOLLOWING MEETS THE ABOVE TEST SPECIFICATION Formal Name: Code Alert CA630 Kind of Equipment: 802.15.4 Transceiver Frequency Range: 2405-2475 MHz Test Configuration: Table Top, with sensor pad and nurse call Model Number(s): 0800-0491 Model(s) Tested: 0800-0491, project name "Sensatec CA630" during testing Serial Number(s): RF Conducted: Prototype device #2 Radiated: Prototype device #1 Duty cycle correction: Prototype device #3 Date of Tests: April 8 th through 10 th , 2013 Test Conducted For: RF Technologies, Incorporated 3125 N 126th Street Brookfield, WI 53005, USA NOTICE: “This test report relates only to the items tested and must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government”. Please see the "Description of Test Sample" page listed inside of this report. © Copyright 1983 - 2013 D.L.S. Electronic Systems, Inc. COPYRIGHT NOTICE This report must not be reproduced (except in full), without the approval of D.L.S. Electronic Systems, Inc. 166 South Carter, Genoa City, WI 53128 Page 2 of 66 Company: RF Technologies, Inc. Model Tested: 0800-0491 Report Number: 18925 DLS Project: 5788 ii. Signature Page SIGNATURE PAGE Tested By: Craig Brandt Test Engineer Reviewed By: William Stumpf OATS Manager Approved By: Brian Mattson General Manager 166 South Carter, Genoa City, WI 53128 Page 3 of 66 Company: RF Technologies, Inc. Model Tested: 0800-0491 Report Number: 18925 DLS Project: 5788 iii. Table of Contents Table of Contents i. Cover Page .......................................................................................................................................1 ii. Signature Page .................................................................................................................................2 iii. Table of Contents .............................................................................................................................3 iv. NVLAP Certificate of Accreditation ...............................................................................................4 1.0 Summary of Test Report ..................................................................................................................5 2.0 Introduction ......................................................................................................................................6 3.0 Test Facilities ...................................................................................................................................6 4.0 Description of Test Sample ..............................................................................................................6 5.0 Test Equipment ................................................................................................................................8 6.0 Test Arrangements ...........................................................................................................................9 7.0 Test Conditions ..............................................................................................................................10 8.0 Modifications Made To EUT For Compliance ..............................................................................10 9.0 Additional Descriptions .................................................................................................................10 10.0 Results ............................................................................................................................................10 11.0 Conclusion .....................................................................................................................................10 Appendix A – Test Photos .........................................................................................................................11 Appendix B – Measurement Data ..............................................................................................................18 1.0 DTS (6 dB) Channel Bandwidth ..........................................................................................18 2.0 Fundamental Emission Output Power .................................................................................22 3.0 Maximum Power Spectral Density (PSD) ...........................................................................26 4.0 Maximum Unwanted Emission Levels - RF Conducted .....................................................30 5.0 Duty Cycle Correction for Pulsed Emissions ......................................................................46 6.0 Unwanted Emissions into Restricted Frequency Bands – Radiated ....................................52 7.0 Band -Edge Measurements – RF Conducted ........................................................................56 8.0 Band -Edge Measurements – Radiated .................................................................................59 9.0 Measurement Data – AC Line Conducted Emissions..........................................................61 166 South Carter, Genoa City, WI 53128 Page 4 of 66 Company: RF Technologies, Inc. Model Tested: 0800-0491 Report Number: 18925 DLS Project: 5788 iv. NVLAP Certificate of Accreditation 166 South Carter, Genoa City, WI 53128 Page 5 of 66 Company: RF Technologies, Inc. Model Tested: 0800-0491 Report Number: 18925 DLS Project: 5788 1.0 Summary of Test Report It was determined that the RF Technologies, Inc. Code Alert CA630 model 0800-0491, complies with the requirements of CFR 47 Part 15 Subpart C Section 15.247. Subpart C Section 15.247 Applicable Technical Requirements Test…

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Setup Photos RF Technologies, Inc. Code Alert CA630 Model 0800-0491 Radiated Front - Below 1GHz Radiated Back - Below 1GHz Radiated Front - Above 1GHz Radiated Front - Above 1GHz - closer view Radiated Back - Above 1GHz RF Conducted AC Line Conducted