Xsensor ForeSite Intelligent Surface System, User Manual

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ForeSite Intelligent Surface System User Guide

Introduction

XSENSOR Technology Corporation

6 of 46

Essential Performance

There is no essential performance. The ForeSite IS system is not intended to replace current best practices for
the prevention of pressure injuries. It is intended to provide additional monitoring and data collection while
standard monitoring techniques and turn schedules are maintained.

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Summary of Contents for ForeSite Intelligent Surface System

Page 1: ...This user guide covers how to install and maintain the ForeSite Intelligent Surface system and its components ForeSite Intelligent Surface System USER GUIDE...

Page 2: ...on The XSENSOR Pressure Imaging System is protected by copyright law Unauthorized reproduction or redistribution of XSENSOR software is prohibited No part of this document may be reproduced or transmi...

Page 3: ...Supply 21 Connecting the Sensor 22 Securing the USB to tablet Connection 23 Finish Making the Bed 25 Maintenance and Cleaning 26 Maintenance 26 Cleaning the Display and Connections 27 Cleaning and Di...

Page 4: ...grated mattress solution and The ForeSite Intelligent Overlay a fitted mattress cover overlay designed to fit over existing hospital mattresses Both options are embedded with a high resolution array o...

Page 5: ...that help clinical staff more effectively execute the pressure relief and patient turning schedules that are commonly included in a medical institution s clinical pathway The device only measures pre...

Page 6: ...ntial Performance There is no essential performance The ForeSite IS system is not intended to replace current best practices for the prevention of pressure injuries It is intended to provide additiona...

Page 7: ...symbols on the components THIS LABEL IDENTIFIES THIS Type B Applied Parts Attention consult accompanying documents Refer to the User Manual for important warnings and operating instructions Type B De...

Page 8: ...g standards Mode of Operation Continuous Class I Equipment Type B Applied Part No electrical contact with patient in normal use Electrical Mechanical Safety IEC 60601 1 2005 A1 2012 Edition 3 1 Electr...

Page 9: ...This includes the power supply or sensor USB cable Warning Do not use the equipment in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Warning The ForeSite IS System i...

Page 10: ...ectly Caution Only use the USB communication cable provided with the ForeSite IS System The USB cable length cannot exceed 10 feet 3 meters Caution Ensure power cords do not trail on the ground to avo...

Page 11: ...Site Intelligent Overlay or ForeSite Intelligent Mattress with embedded sensors 19 VDC 3 15 A AC DC power supply Power adapter cord USB extension cable sensor to display terminal Reusable cable tie zi...

Page 12: ...12 of 46 Display Terminal Status Lights The two lights on the front of the Display Terminal show the following states Power Top LED Green when on Off when off Battery Charging Bottom LED Red when low...

Page 13: ...e equipment to a receptacle with proper electrical grounding The type of attachment plug can vary according to the country in which it is being used Following are examples of attachment plugs used in...

Page 14: ...cable and power supply cables for signs of damage including but not limited to tears cracks and or exposed wiring If damage to system cables is identified or suspected return them immediately to XSENS...

Page 15: ...e Intelligent Surface Overlay is a fitted mattress cover designed to fit over existing hospital mattresses that strap to their bed frames Unroll the overlay and place it so the zippered pocket is on t...

Page 16: ...ogy Corporation 16 of 46 3 4 Grab the bottom edge of the overlay and tug on it gently to ensure that the top half of the overlay is flush with the top edge of the mattress Push down the flap at the bo...

Page 17: ...ystem User Guide Installation XSENSOR Technology Corporation 17 of 46 5 Each corner has a strap originating from the short ends of the overlay Grab that strap with one hand Feed the overlay strap unde...

Page 18: ...e overlay about 2 5 feet from the corner A buckle will be located on the underside Feed the strap through the backside of the top buckle slot Feed the strap through the front of the bottom buckle slot...

Page 19: ...Surface System User Guide Installation XSENSOR Technology Corporation 19 of 46 9 10 Optional If desired roll up any excess length of strap and tuck into the nearby strap loop Repeat Steps 5 10 for al...

Page 20: ...rporation 20 of 46 1 Installing the ForeSite Intelligent Mattress The ForeSite Intelligent Mattress combines a mattress and a pressure sensor into a single integrated unit Arrange the mattress such th...

Page 21: ...ing the Power Supply Insert the power supply connector into the charging port on the side of the Display Terminal If your system includes the power supply brace align the power supply connector betwee...

Page 22: ...USB connector into the female end of the USB extension cable If your system includes the USB USB connector brace slide it onto the two connected cable ends Insert the male end of the USB extension cab...

Page 23: ...o the tablet with the reusable zip tie Position the USB cable along the side of the Display Terminal Be sure to leave enough slack so the USB cable does not kink or put extra strain on the USB connect...

Page 24: ...2 To remove the zip tie The underside of the locking slot on the zip tie has a release tab Slide a fingernail or small screwdriver blade under the tab Push the tab down away from the teeth on the zip...

Page 25: ...system with your hand Cover the system with a fitted cotton sheet and finish making the bed Warning The ForeSite IS System is not intended for direct contact with the patient and must be covered with...

Page 26: ...nd Cleaning Maintenance There are no serviceable parts on the ForeSite IS System Refer to Contact Information for instructions on finding an authorized repair facility Thoroughly clean the ForeSite IS...

Page 27: ...rosion and damage Use only a soft dry cloth to wipe the connectors Spray a clean absorbent non shedding soft cloth with one of the cleaning disinfectants listed in Cleaning and Disinfecting the Sensor...

Page 28: ...leach wipe rinse cycles Remove the cotton sheet covering the system prior to performing the cleaning procedure Prepare a bleach solution by diluting common household bleach at a 1 10 dilution H2O Usin...

Page 29: ...XSENSOR Technology Corporation 29 of 46 H2O Using a disinfectant wipe example CaviWipes wipe the sensor Allow the fabric to stay wet for 3 minutes Using a new disinfectant wipe example CaviWipes wipe...

Page 30: ...ng alcohol bleaching or abrasive material may be harmful Contact XSENSOR before using any disinfectant not listed above Caution Under no circumstances should a phenolic based cleaning solution be used...

Page 31: ...ting the Sensor Surface If the system is about to be used for a new patient clean with a disinfectant wipe example CaviWipes Remove the bedding and lower the bed rails to expose the system Using a dis...

Page 32: ...intenance and Cleaning XSENSOR Technology Corporation 32 of 46 1 Cleaning the Mattress Underneath the ForeSite Intelligent Overlay Remove the system or push it to the side and wipe the mattress undern...

Page 33: ...system can be folded in half or completely flipped over to access the underside If working with the ForeSite Intelligent Mattress the system can be flipped over to access the underside Disconnect the...

Page 34: ...the Display Terminal and the ForeSite Intelligent Mattress and place cable and Display Terminal in original packaging The USB cable attached to the mattress can be coiled up and tucked into the pouch...

Page 35: ...telligent Surface System User Guide Maintenance and Cleaning XSENSOR Technology Corporation 35 of 46 2 3 Pull upwards on the tab of the buckle to loosen the strap Pull the strap up out of the bottom b...

Page 36: ...Guide Maintenance and Cleaning XSENSOR Technology Corporation 36 of 46 4 5 6 Pull the strap to remove it from the buckle entirely Repeat steps 1 4 for each corner strap Lift the straps out from under...

Page 37: ...rface System User Guide Maintenance and Cleaning XSENSOR Technology Corporation 37 of 46 7 8 Flip the overlay upside down and place the provided foam block at the foot end Bring the foot edge and stra...

Page 38: ...Cleaning XSENSOR Technology Corporation 38 of 46 9 10 Place the straps inside and fold the edges inward Fold the bottom edge over the foam block to start rolling the overlay around the foam block Roll...

Page 39: ...emperature 4 to 140 F 20 to 60 C Relative Humidity 10 to 90 non condensing Atmospheric Pressure 0 50 to 1 06 bar Fold the ForeSite overlay as described in Storing the System and Display Terminal Do no...

Page 40: ...enance and Cleaning XSENSOR Technology Corporation 40 of 46 End of a System s Product Life When a system has been damaged or reached the end of its product life please contact XSENSOR or your local XS...

Page 41: ...cs MDS 060AAS19 B Dimensions 62 mm x 135 mm x 34 1 mm Weight 360 g Input 100 250 VAC 50 60 Hz 1 5 0 75 A Output 19 VDC 3 15 A Case Material Plastic SENSOR ForeSite IS Sensor array 26 x 64 sensels Sens...

Page 42: ...tem User Guide Specifications XSENSOR Technology Corporation 42 of 46 SYSTEM Risk Management EN ISO 14971 Electrical Mechanical Safety IEC 60601 1 2005 A1 2012 Edition 3 1 Electromagnetic Compatibilit...

Page 43: ...equipment Radio frequency disturbance characteristics IEC 61000 3 2 2014 Limits for Harmonic Current Emissions equipment input current 16A per phase IEC 61000 3 3 2013 Limitation of Voltage Changes Vo...

Page 44: ...relocating the ForeSite IS System or shielding the location Harmonic Emissions IEC 61000 3 2 Class B Voltage Fluctuations Flicker Emissions IEC 61000 3 3 Complies IEC 60601 1 2 2014 The ForeSite IS S...

Page 45: ...should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of known RF transmitting devices and equipment marked with the following symbol NOTE 1 At 80 M...

Page 46: ...sentative in the EU Advena Ltd Tower Business Centre 2nd Flr Tower Street Swatar BK4 4013 Malta Tel 356 2546 6689 Web advenamedical com XSENSOR Authorized Representative in Australia Emergo 201 Sussex...

Page 47: ...Avenue SE Calgary AB T2G 0Z9 Canada support xsensor com www xsensor com 1 403 266 6612 North America Toll Free 1 866 927 5222 Copyright 2021 XSENSOR Technology Corporation All rights reserved includi...

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