RYM-LAL1001AFXI Low Air Loss Surface Power Unit

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…

Text truncated - open the document above for the full version.

MODEL: LAL1001 100-240VAC, 50-60Hz 15Watts Max IP24 ETL CLASSIFIED Mfg: 09-26-12 Rev A FCC ID RYM-LAL1001A FXI Rose Tree Corporate Center II 1400 North Providence Road Suite 2000 Media PA 19063-2076 800.355.3626 Medical Electrical Equipment UL 60601-1, IEC 60601-2, CAN/CSA C22.2 No. 601.1 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. SN: XXXXXXXX XXX 25 23 38 20 26 36 30 22 35 33 37 28 34 29 21 32 31 24 27 24 rA.03 AA 01/03/2013 REVISIONS REVECDESCRIPTIONDATEBY rA.01INITIAL DESIGN07/19/2012AA rA.02 Noted new components 10/03/12AA ITEM NO. PART NO.DESCRIPTIONQTY 19FX01-20407Front Enclosure, SPU1 20FX01-20405Top Enclosure, SPU1 21FX01-20406Bottom Enclosure, SPU 1 22FX01-20408Barb Insert, SPU1 23FX01-ART03Label Front Enclosure, SPU1 24FX01-ART07Label Declaration, SPU1 25HC-0.25A-EM-A3Blower Gasket (Embossed Foam Seal)1 26BFB1012HBlower (x1)1 27TR9CE5000LRP-C-MEDExternal power supply (12VDC 5.0A)1 2894744A224Washer, No 8, 1/2"OD (x2)2 293504T16Push On Round Cap White 2 3090126A509Washer, No 6, 3/8"OD (For Webbing) x11 311818(5.5mm) Strain Relief x11 3290380A106THForming, 4-20, 1/4" (Pan) x54 3390055A146THForming, 6-20, 3/8 (Flat Head Screw) x44 3492295A205THForming, 6-19, 3/8" (Pan Head Screw) x66 3590272A204Machined, 8-32, 1-3/4"(Pan Head Screw) x22 3690480A009Screw Nut, 8-32, 1/8"Height (x2)2 379600K23Push In Grommet (x2)2 38FX01-3402Assembled PCB1 D C B A A B C D SCALE: 1:8 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 SPU Assembly Gen1 A.02 3201 AA See Note 1 See Note 2 +/- .015 .XX +/-.01 +/- 0.5 .XXX +/-.005 11/03/2012 SIZE DATE DESIGN SHEET CAD FILE: FX01-3201-rA.02-Control Unit Assembly Gen 1 Exploded 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 Title NumberRevisionSize B Date:1/21/2013Sheet of File:J:\JOBS\..\1617_001b_FXI_Symbioso_SPU_CPLD.SchDocDrawn By: GPO_[8..0] GPO_[8..0] CPLD Sheet B 22 JCW 1617_001 B A N K A IO 2 IO 3 IO 5 IO 6 IO 8 IO 10 IO 12 IO 13 IO 14 IO 15 IO 44 IO 43 IO 42 U7A EPM3032ATC44-10N B A N K B IO 35 IO 34 IO 33 IO 31 IO 28 IO 27 IO 25 IO 23 IO 22 IO 21 IO 20 IO 19 IO 18 U7B EPM3032ATC44-10N INPUT/GCLK1 37 INPUT/GCLRn 39 INPUT/OE1 38 INPUT/OE2/GCLK2 40 U7C EPM3032ATC44-10N IO/TDI 1 IO/TDO 32 IO/TCK 26 IO/TMS 7 U7D EPM3032ATC44-10N VCCINT(3.3V) 41 VCCINT(3.3V) 17 VCCIO(2.5V OR 3.3V) 29 VCCIO(2.5V OR 3.3V) 9 U7E EPM3032ATC44-10N GNDINT 36 GNDINT 16 GNDIO 30 GNDIO 24 GNDIO 11 GNDIO 4 U7F EPM3032ATC44-10N +3.3V +3.3V 1 2 3 4 5 6 P11 P1X6 +3.3V 1 0 K R 5 6 1 0 K R 5 7 1K R 5 1 +3.3V PUMP_B_CTRL_2 VALVE _A _CTRL PUMP_A_CTRL_2 VALVE _B _CTRL R52 100 LD1 GREEN LD2 GREEN LD3 GREEN LD4 GREEN SW2 SW3 GPO_0 GPO_1 GPO_2 GPO_3 GPO_4 GPO_5 GPO_6 GPO_7 GPO_8 PUMP_A_CTRL_1 PUMP_B_CTRL_1 0 . 1 u F C 5 1 0 . 1 u F C 5 2 RESET_N R53 100 R54 100 R55 100 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 Surface Power Unit 1617_001B 1/21/20139:48:21 AM 1617_001b_FXI_Symbioso_SPU.SchDoc Title Size:Number: Date: File: Revision: SheetofTime: C +24V 100nF C101 VDD_CC2530 100nF C211 100nF C240 100nF C271 220pF C272 100nF C311 2u2F C61 Ferrite Bead, 1000 ohm L1+3.3V R301 56K 27PF C231 27PF C221 15PF C331 15PF C321 1.0nH L41 1.0nH L21 1pF C42 1pF C22 10pF C21 10pF C41 1K R1421K R72 Ferrite Bead, 1000 ohm L2 2.2pF C20 1pF C11 VDD_CC2590 1nF C161 1nF C131 1nF C102 18pF C103 14K3 R151 Ferrite Bead, 1000 ohmL102 2 . 2 n H L 1 1 1 6 p 8 F C 1 1 2 2p7F C113 1p5F C111 1.5nH L112 RESET_N 1 2 P7 PUMP_A_CTRL_1 BUZZER CTRL BLOWER CTRL BUZZER CTRL USB_P USB_N 1 2 B1 BUZZER250 RESET_N +3.3V +12V +3.3V DEBUG_DATA DEBUG_DATA DEBUG_CLK VBUS 1 D- 2 D+ 3 GND 4 SHLD 5 J1 Jack_USB_MINI USB_P USB_N DNIR39 DNIR20 DNI C7 DNI C8 10K R1 47K R2 100 R3 12 P1 PUMP_A_CTRL_2 10K R8 47K R7 100 R6 +12V SENSOR_A_Vout +3.3V SENSOR_A_Vout SENSOR_B_Vout 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 GND 41 DVDD_USB 4 USB_N 3 USB_P 2 DGND_USB 1 U1CC2531 TRIM DN DNI R9 TRIM UP DNI R10 +12V 1 2 P8 2 1 3 Q32 1 3 Q5 2 1 3 Q1 2 1 3 Q6 DNI R40 DVDD_USB + Input 1 - Input 2 CTRL 3 - Sense 4 + Sense 5 + Output 6 - Output 7 Trim 8 PXF60-24S12 U5 DNI SW2 +3.3V PUMP_B_CTRL_1 10K R11 47K R12 100 R13 12 P2 PUMP_B_CTRL_2 10K R18 47K R17 100 R16 +12V 2 1 3 Q13 2 1 3 Q15 2 1 3 Q112 1 3 Q16 SW3 +3.3V GPO_[8..0] GPO_[8..0] GPO_0 GPO_1 GPO_2 GPO_3 GPO_4 GPO_5 GPO_6 GPO_7 21 SW2 21 SW1 DNI 1 8 4 3 2 V+ V- U10A LF412CN-SO8 +3.3V 1.00M 1% R62 1.00M 1% R63 30.1K 1% R61 30.1K 1%R60 SENSOR_B_Vout +3.3V 7 5 6 V+ V- U10B LF412CN-SO8 1 . 0 0 M 1 % R 6 7 1 . 0 0 M 1 % R 6 8 30.1K 1%R66 30.1K 1%R65 1K R112 VALVE _A _CTRL BLOWER CTRL 1 2 P4 +12V 1 2P3 DVDD_USB GPO_8 GND 1 +Vout 2 Vs 3 -Vout 4 NC 5 NC 6 NC 7 NC 8 13-0014-003 U3 Sensor1 GND 1 +Vout 2 Vs 3 -Vout 4 NC 5 NC 6 NC 7 NC 8 13-0014-003 U4 Sensor1 +12V 21 SW3 1 p 5 F C 1 1 4 0 R 1 8 2 ANTENNA OPTION Connect other wires for valves to +12V at P8 MH5MH4 MH3 MH2MH1 +12V_IN +24V_IN RF_P RF_N RF_N_90 RF_P_90 D1 D2 P0220SCLRP F24 F12 4A NCP1117ST33 G N D 1 IN 3 OUT 2 OUT 4 U6 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 AVDD_PA1 1 GND 17 U2CC2590 C2 DNI C1 DNI 1uF C391 C3 0.1uF 25V C4 10uF 16V C5 10uF 16V 10K R31 10K R29 10K R32 270R30 R90 DNI ANT1 2 1 3 Q4 2 1 3 Q14 2 1 3 Q2 2 1 3 Q12 VALVE _B _CTRL Q41 Q40 Q28 FDN335N 2 1 3 Q29 FDN335N ANT2 32.768kHz X2 C10DNI 1N4148WS D3 Don't connect MH3 to GND. 1uF C401 Not installed Not installed Not installed Not installed Not installed 5 2 3 1 4 J2 P1X5 +3.3V C9 0.1uF DEBUG_CLK RESET_N CPU Programming Port 4 32MHz 10ppm X1 1uF C6 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 Surface Power Unit Page 1 of 62 EMISSIONS TEST REPORT Report Number: 100806529BOX-014a Project Number: G100806529 Report Issue Date: 08/28/2012 Product Designation: Surface Power 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-014a Issued: 08/28/2012 Emissions Report for FXI, Inc. on the Surface Power 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), CFR47 Part 2.1091) 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 12 AC Mains Conducted Emissions FCC Part 15:2011 Section 15.207 (a) RSS-Gen Issue 3 December 2010, 7.2.2 (Table 2) Pass 13 Revision History -- Intertek Report Number: 100806529BOX-014a Issued: 08/28/2012 Emissions Report for FXI, Inc. on the Surface Power 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 Surface Power Unit FXI, Inc. SPU BOX1208061022-004 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 100-240 VAC 1.5 A 50-60 Hz 1 Operating modes of the EUT: No. Descriptions of EUT Exercising 1 Transmit 2 Idle/Receive Intertek Report Number: 100806529BOX-014a Issued: 08/28/2012 Emissions Report for FXI, Inc. on the Surface Power Unit Page 4 of 62 5 System Setup and Method Cables Qty Description Length (m) Shielding Ferrites Termination 1 AC Adapter 1.59 None Yes Power Supply 1 AC Mains 2.31 None None AC Mains Support Equipment Description Manufacturer Model Number Serial Number AC Power Adapter GlobTek, Inc. TR9CE5000LRP-C-MED RoHS100136126/11 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 2010 , RSS-Gen Issue 3 December 2010, and KDB 558074v01 06/15/20…

Text truncated - open the document above for the full version.