RYM-LAL1001FXI Low Air Loss Surface Wireless Pendant Control

1 Manual PRELIMINARY PRELIMINARY Distributed by: FXI Rose Tree Corporate Center II 1400 North Providence Road Suite 2000 Media, PA 19063-2076 800-355-3626 No part of this manual will be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information or retrieval system without prior written permission from FXI. The information in this manual is confi dential and proprietary and may not be disclosed to third parties without the prior written consent of FXI. The information contained in this manual is subject to change without notice. FXI reserves the right to make changes without notice in design, specifi cations, and models. FXI makes no commitment to update or keep current, the information contained in this manual. FXI provides a written warranty on the sale of its products only. 2 FXI Power Play User Manual FXI Power Play Manual rev.24 01/25/13 3 3 FXI Power Play User Manual FXI Power Play Manual rev.24 01/25/13 TABLE OF CONTENTS Important Safeguards..................................................................................................................................4 Introduction.......................................................................................................................................6 Pressure relief.......................................................................................................................................6 Moisture control.....................................................................................................................................6 Shear and friction reduction....................................................................................................................6 Indications for use.........................................................................................................................................7 Pressure relief.......................................................................................................................................7 Pain management.................................................................................................................................7 Features.............................................................................................................................................................8 Grounding Instructions...................................................................................................................................10 System Specifi cations.....................................................................................................................................11 ElectricalSpecifi cation.........................................................................................................................11 EnvironmentalConditions............................................................................................................................11 Agency Approvals..........................................................................................................................................12 EMC Considerations......................................................................................................................................13 Setup..............................................................................................................................................................17 Operation........................................................................................................................................................19 Nursing Procedures.........................................................................................................................................19 Patient Comfort Controls and Monitoring..............................................................................................,.........21 Other Features..................................................................................................................................................22 Suspend/Disable Low Air Loss Therapy....................................................................................................22 Transport.................................................................................................................................................22 Power failure................................................................................................................................................22 Cleaning..........................................................................................................................................................23 General cleaning...................................................................................................................................23 Disinfecting.....................................................................................................................................................24 Steam cleaning......................................................................................................................................24 Maintenance..............................................................................................................................................24 Storage and Care..............................................................................................................................................24 Call for Assistance...........................................................................................................................................24 4 FXI Power Play User Manual FXI Power Play Manual rev.24 01/25/13 IMPORTANT SAFEGUARDS Read ALL Instructions BEFORE Using This Product IMPORTANT NOTICE: The equipment has to be installed and operated in the manner for which it was intended. Facility staff/user is responsible for reading and understanding the product use…

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ETL CLASSIFIED Mfg: 09-26-12 Rev A MEDICAL ELECTRICAL EQUIPMENT UL 60601-1, IEC 60601-2 CAN/CSA C22.2 NO. 601.1 xxxx FCC ID RYM-LAL1001 1 2 3 10 16 11 12 13 15 4 9 8 15 5 6 7 17 17 rA.03 AA 1/03/2013 ITEM NO. PART NUMBERDESCRIPTIONQTY. 1FX01-20401Top Enclosure, Pendant1 2FX01-20402Bottom Enclosure, Pendant1 3FX01-20404Molded Gasket, Pendant1 4FX01-20403Battery Door, Pendant1 5FX01-AR05Label Serial Number1 6FX01-AR06Label Declaration1 7FX01-ART01Label Pendant Gen 11 8FX01-21001Battery Door Gasket, Pendant1 9FX01-21002Sounder Gasket, Pendant1 10FX01-3401PCB Assembly, Pendant 1 112465Battery Holder, Pendant1 1290380A106 Thread Forming, 4-20, 1/4"(Pan) x10 10 1395893A212 Thread Forming, 4-20, 1/4"(Flat) x2- 1 1496877A209Machined, 4-40, 3/8" (Flat) x22 1593365A122 Threaded Inserts, 4-40, .135 Short 2 1616FWRT004032 Retaining Lock Washer Nylon x2 2 17TP3/8-10 Plastic Sliders For Webbing 3/8" x1 2 18WN3-8SIL10Nylon Webbing (Silver) 3/8"1 REVISIONS REV.ECDESCRIPTIONDATEBY A.01INITIAL DESIGN07/19/12AA A.02 Named new Components 10/03/12AA D C B A A B C D SCALE: 1:4 DWG. NO. B 1 of 1 REV. UNLESS OTHERWISE SPECIFIED DIMENSIONS ARE IN INCHES TOLERANCES APPLY AFTER FINISHING. TOLERANCES ARE: FRACTIONS DECIMALS ANGLES MATERIAL FINISH 123 456 7 8 8 7 6 5 4 32 1 Pendant Assembly Gen1 A.02 3202 AA See Note 1 See Note 2 +/- .015 .XX +/-.01 +/- 0.5 .XXX +/-.005 10/03/2012 SIZE DATE DESIGN SHEET CAD FILE: FX01-3202-rA.01-Pendant Assembly Exploded View Nexus Design, llc 1 Jacks Hill Road Oxford, CT 06478 Phone: 203-888-1564 Fax: 203-888-1568 www.nexusdesignllc.com

Functional Description of the FXI Symbioso control system and wireless remote. RF Hardware and Control Protocol The FXI mattress control system consist of two parts, a control unit contains the power supply, blower and microcontroller system with an integral 2.4GHz IEEE 802.15.4 compliant RF transceiver and a remote unit that controls the functions of the mattress unit and contains an identical microprocessor and integrated transceiver module. The mattress control unit and the remote control unit are designed around a Texas Instruments (TI) CC2531 (Datasheet attached) and CC2590 chip set operating the ZigBee RF4CE protcol standard. The CC2590 is a combination LNA and PA chip designed to operate in conjunction with the CC2531. The mattress control unit is powered from an external 12vdc power supply and regulated down to 3.3vdc for the CC2531 and the CC2590. The remote control unit is powered from three 1.5v AA alkaline cells and again regulated down to 3.3vdc for the CC2531 and CC2590 chips. Both units contain an integral PCB antenna formally designated as a 2.4 GHz inverted ‘F’ antenna. Maximum gain is measured to be +3.3db and the overall size is 25.7 x 7.5 mm. The antenna is designed to have a 50 ohm feed point with no ground plane located behind the antenna. (See TI design note DN0007). Inverted F antenna shown aprox. Full size. 1.007 0.05 0.65 0.11 0.09 0.05 0.23 A full description of the ZigBee RF4CE protocol functionality is given in the attached PDF file. Jack Provenzano Engineering Manager Pergamon Corp.

1 1 2 2 3 3 4 4 5 5 6 6 DD CC BB AA 1 Pergamon Corporation 380 Crooked Ln. Unit #3 King of Prussia, PA 19406 USA 1 FXI Symbioso Remote Pendant 1617_002B 1/21/201310:35:01 AM 1617_002b_FXI_Symbioso_Remote.SchDoc Title Size:Number: Date: File: Revision: SheetofTime: C 21 S1 21 S3 21 S5 POWERI PAIRI ALARM_RESETI 21 S2 FIRM_LEVEL R34 150 21 S4 APM_MODE LD13 GREEN R14 150 +3.3V LD1 GREEN OE 13 RCLK 12 SER 14 SRCLR 10 SRCLK 11 QA 15 QB 1 QC 2 QD 3 QE 4 QF 5 QG 6 QH 7 QH' 9 VCC 16 GND 8 U3 SN74HC595D R17 150 LD2 GREEN R19 150 LD3 GREEN R21 150 LD4 GREEN R22 150 LD5 GREEN R24 150 LD6 GREEN R26 150 LD7 GREEN R27 150 LD8 GREEN +3.3V R9 10K +3.3V R16 10K +3.3V R15 10K LED_DATA LED_SCLK LED_RCLK POWERI PAIRI ALARM_RESETI FIRM_LEVEL APM_MODE 21 S6 LAL_MODE R23 10K +3.3V LAL_MODE R32 10K RESET_N 21 S7 DNI +3.3V 1 2 BZ1 BUZZER1 R25 133 1% R28 47.5 1% BATMONI VIN 12 F1 2.0A C31 1000PF + C30 10UF ADJ 4 EN 3 IN 1 G N D 2 OUT 5 U5 MIC5235-3.3YM5 TR C29 0.1UF VIN +3.3V 12 D1 SMAZ6V2-13-F +4.5V BATTERY CONNECTION RF_P 4 RXTX 3 RF_N 2 PAEN 5 EN 6 HGM 7 ANT 11 PABIAS 15 AVDD_PA2 10 AVDD_LNA 13 AVDD_BIAS 16 GND 8 GND 9 GND 12 GND 14 CC2590 U? AVDD_PA1 1 GND 17 U2 CC2590 100nF C1 1uF C5 100nF C6 100nF C7 100nF C8 220pF C9 100nF C10 2u2F C2 Ferrite Bead, 1000 ohm L1 56K R3 27PF C22 27PF C23 15PF C24 15PF C25 1.0nH L5 1.0nH L4 1pF C18 1pF C13 10pF C14 10pF C17 1K R51K R4 Ferrite Bead, 1000 ohm L2 2.2pF C3 1pF C4 1nF C11 1nF C12 1nF C15 18pF C16 4K3 R2 Ferrite Bead, 1000 ohmL3 2.2nH L6 6p8F C21 2p7FC26 1p5F C19 1.5nHL8 RESET_N USB_P USB_N P0_7 12 P0_6 13 P0_5 14 P0_4 15 P0_3 16 P0_2 17 P0_1 18 P0_0 19 P1_0 11 P1_1 9 P1_2 8 P1_3 7 P1_4 6 P1_5 5 P1_6 38 P1_7 37 P2_0 36 P2_1 35 P2_2 34 XOSC32K_Q2 / P2_3 33 XOSC32K_Q1 / P2_4 32 RBIAS 30 RESET_N 20 RF_N 26 RF_P 25 XOSC_Q1 22 XOSC_Q2 23 AVDD1 28 AVDD2 27 AVDD3 24 AVDD4 29 AVDD5 21 AVDD6 31 DCOUPL 40 DVDD1 39 DVDD2 10 CC2531 U? GND 41 DVDD_USB 4 USB_N 3 USB_P 2 DGND_USB 1 U1 CC2531 DNP R1 DVDD_USB 1K R7 1p5F C27 ANT1 RF_P RF_N RF_N_90 RF_P_90 LED_DATA LED_SCLK LED_RCLK ANT2 MH5MH4MH2MH1MH3 VBUS 1 D- 2 D+ 3 GND 4 SHLD 5 J2 Jack_USB_MINI USB_P USB_N R35 R36 0.1uF C32 0.1uF C33 DVDD_USB DEBUG_DATA DEBUG_CLK OE 13 RCLK 12 SER 14 SRCLR 10 SRCLK 11 QA 15 QB 1 QC 2 QD 3 QE 4 QF 5 QG 6 QH 7 QH' 9 VCC 16 GND 8 U4 SN74HC595D +3.3V X2-32 X2-33 X1-22 X1-23 DCOUPL 32.768kHz X2 USB_P USB_N DVDD_USB DEBUG_DATA DEBUG_CLK LED_RCLK LED_SCLK LED_DATA RESET_N POWERO PAIRO ALARM_RESETO APMOFF PAIRI ALARM_RESETI POWERI BATMONI BUZZER1 BATMONI LOWBATT R29 150 LD9 GREEN R30 150 LD10 GREEN R31 150 LD11 RED R33 150 LD12 RED +3.3V BUZZER1 BUZZER1 FIRM_LEVEL LAL_MODE APM_MODE R18 10K R13 10K R8 10K +3.3V +3.3V 2 1 3 Q1 FDN335N 2 1 3 Q3 FDN335N 2 1 3 Q2 FDN302P 10K R20 BAT_SENSE BAT_SENSE BAT_SENSE 1 2 J1 +3.3V 0 R6 1uF C20 VDD_CC2530VDD_CC2590 1N4148WS D3 Leave MH4 & MH5 unconnected for antenna 4 32MHz 10ppm X1 Not installed DEBUG_DATA 5 2 3 1 4 J3 P1X5 +3.3V DEBUG_CLK RESET_N CPU Programming Port C28 0.1UF R11 47 Not installed FID1 FID2

This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Emissions Report for FXI, Inc. on the Wireless Pendant Control Unit Page 1 of 62 EMISSIONS TEST REPORT Report Number: 100806529BOX-014 Project Number: G100806529 Report Issue Date: 08/28/2012 Product Designation: Wireless Pendant Control Unit Standards: FCC Part 15:2012 Subpart C Section 15.247, FCC Part 15:2012 Subpart B Class B, RSS-210 Issue 8 December 2010, ICES-003 Issue 4 February 2004, RSS-Gen Issue 3 December 2010+Notice 2012-DRS-0126 IC RSS-102 Issue 4 March 2010 Tested by: Client: Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719 FXI, Inc. 120 Concord Road Aston, PA 19014 Report prepared by Report reviewed by Kouma Sinn / Senior Project Engineer, EMC Nicholas Abbondante / Transmitter Staff Engineer Intertek Report Number: 100806529BOX-014 Issued: 08/28/2012 Emissions Report for FXI, Inc. on the Wireless Pendant Control Unit Page 2 of 62 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. 2 Test Summary Section Test full name Result 3 Client Information -- 4 Description of Equipment Under Test -- 5 System Setup and Method -- 6 RF Output Power, Human RF Exposure and Duty Cycle (CFR47 FCC Part 15 Subpart C 15.247(b)(3), KDB 558074v01 06/15/2012, IC RSS-210 A8.4(4), IC RSS-102 Issue 4 March 2010, CFR47 Part 2.1093) Pass 7 Transmitter Radiated Spurious Emissions (CFR47 FCC Part 15 Subpart C 15.247(d), IC RSS-210 A8.5, KDB 558074v01 06/15/2012 Section 5.4) Pass 8 6 dB Bandwidth (CFR47 FCC Part 15 Subpart C 15.247(a)(2), IC RSS-210 A8.2(a), IC RSS-Gen Section 4.6.2, KDB 558074v01 06/15/2012 Section 5.1) Pass 9 Peak Power Spectral Density (FCC 15:2011 Subpart C Section 15.247 (e), RSS-210 Issue 8 December 2010, A8.2 (b), KDB 558074v01 06/15/2012 Section 5.3) Pass 10 Band Edge Compliance (FCC 15:2011 Subpart C Section 15.247 (d), RSS-210 Issue 8 December 2010, A8.5, KDB 558074v01 06/15/2012 Section 5.4.2.2.4) Pass -- Receiver Radiated Spurious FCC Part 15:2012 Subpart B Section 15.109 (a) RSS-Gen 3 December 2010, Section 6 Exempt, above 960MHz 11 Digital Device Radiated Spurious Emissions (CFR47 FCC Part 15 Subpart B 15.109, IC ICES-003 Issue 4 February 2004) Pass -- AC Mains Conducted Emissions FCC Part 15:2011 Section 15.207 (a) RSS-Gen Issue 3 December 2010, 7.2.2 (Table 2) N/A 12 Revision History -- Notes: The AC Mains conducted emissions test is not applicable as the EUT is battery powered. Intertek Report Number: 100806529BOX-014 Issued: 08/28/2012 Emissions Report for FXI, Inc. on the Wireless Pendant Control Unit Page 3 of 62 3 Client Information This EUT was tested at the request of: Company: FXI, Inc. 120 Concord Road Aston, PA 19014 Contact: Mr. Chris Weyl Telephone: (610) 245-2742 Fax: None Email: [email protected] 4 Description of Equipment Under Test Equipment Under Test Description Manufacturer Model Number Serial Number Wireless Pendant Control Unit FXI, Inc. Pendant BOX1208061022-001 Receive Date: 08/06/2012 Received Condition: Good Type: Production Description of Equipment Under Test (provided by client) The product will be a low-cost advanced pressure redistribution support surface for patients at risk from bed sores with the ability to deliver low air loss (LAL) therapy via modular plug-and- play variants. The support surface will maintain support characteristics in its static, non- powered state. The system will be comprised of a 12v powered blower/ pump control unit powered thru a Hospital grade, in line, power supply. The control unit is embedded in the side of a multilayer foam mattress. The Control unit shall actuated be from a wireless handheld pendant device. This product is intended to service primarily the acute care and long term care environments. The device utilizes an integral antenna and operates in the range from 2405 to 2480 MHz. Equipment Under Test Power Configuration Rated Voltage Rated Current Rated Frequency Number of Phases 3 Alkaline AA Batteries N/A N/A N/A Operating modes of the EUT: No. Descriptions of EUT Exercising 1 Transmit 2 Idle/Receive Intertek Report Number: 100806529BOX-014 Issued: 08/28/2012 Emissions Report for FXI, Inc. on the Wireless Pendant Control Unit Page 4 of 62 5 System Setup and Method Cables Qty Description Length (m) Shielding Ferrites Termination None Support Equipment Description Manufacturer Model Number Serial Number None 5.1 Method: Configuration as required by ANSI C63.4:2003, FCC Part 15:2012 Subpart C Section 15.247, RSS-210 Issue 8 December…

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