Xsensor ForeSite Intelligent Surface System User Manual

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U S E R G U I D E

ForeSite

Intelligent

Surface System

This user guide covers how to install and maintain the

ForeSite Intelligent Surface system and its components.

Table of Contents

Summary of Contents for Xsensor ForeSite Intelligent Surface System

Page 1 U S E R G U I D E ForeSite Intelligent ® Surface System This user guide covers how to install and maintain the ForeSite Intelligent Surface system and its components.
Page 2 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 transmitted in any form without the express written permission of XSENSOR Technology Corporation.
Page 3: Table Of Contents
Storing the System and Display Terminal ......................34 Storage and Transport Conditions........................39 End of a System's Product Life .......................... 40 Specifications ..................... 41 Specifications..............................41 Compliance with Emission and Immunity Standards ..................43 Contact Information ................... 46 Contact Information............................46 XSENSOR Technology Corporation 3 of 46...
Page 4: Introduction
The ForeSite® Intelligent Surface System (ForeSite IS) is a continuous skin monitoring mattress system for clinicians that improves patient safety and reduces staff workload. It’s powered by XSENSOR’s Intelligent Dynamic Sensing platform, which enables precise measurements and features highly detailed visualizations and smart data with AI-powered analysis —...
Page 5: Intended Use
Introduction Intended Use The ForeSite Intelligent Surface System is specifically intended to assist with the turn management and repositioning of patients susceptible to pressure injuries in medical, nursing and long term-care facilities. The ForeSite IS system provides continuous monitoring features that help clinical staff more effectively execute the pressure relief and patient turning schedules that are commonly included in a medical institution’s clinical...
Page 6: Essential Performance
ForeSite Intelligent Surface System User Guide Introduction 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.
Page 7: Symbol Guide
ForeSite Intelligent Surface System User Guide Introduction Symbol Guide The ForeSite Intelligent Surface System uses the following 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 ...
Page 8: Compliance With Standards
ForeSite Intelligent Surface System User Guide Introduction Compliance with Standards The ForeSite IS System is compliant with the following standards: • Mode of Operation: Continuous • Class I Equipment • Type B Applied Part. No electrical contact with patient in normal use •...
Page 9: Warnings And Cautions
To ensure safe use of the product, follow all safety and operating instructions in this guide. At the end of your system's product life, please contact XSENSOR for instructions for safe disposal. The ForeSite IS System is intended for use by healthcare professionals only. ForeSite IS must be installed and used as described in this User Guide.
Page 10 Caution: Avoid damage to the Display Terminal. Never place or rest another object on it while it is not in use. If any of these warnings or cautions are unclear, please contact XSENSOR Technology Corporation immediately for more information. XSENSOR Technology Corporation ...
Page 11: Description Of Components
Power cord brace USB adapter brace USB-USB connector brace Note: The brace components are not supplied with all systems. Contact XSENSOR Support if you need the braces but they were not supplied with your system. XSENSOR Technology Corporation 11 of 46...
Page 12 ForeSite Intelligent Surface System User Guide Introduction 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 battery. Flashing white when charging. Solid white when battery is fully charged.
Page 13: Power Supply And Power Cord
ForeSite Intelligent Surface System User Guide Introduction Power Supply and Power Cord Use only the ForeSite IS System supplied power supply with the ForeSite IS System. Before using the ForeSite IS system, verify that the power supply is model Delta Electronics MDS-060AAS19 B.
Page 14: Installation
If damage to the system is identified or suspected, return it immediately to XSENSOR for repair or replacement. Inspect USB cable and power supply cables for signs of damage including, but not limited to, tears, cracks, and/or exposed wiring.
Page 15: Installing The Foresite Is Overlay
ForeSite Intelligent Surface System User Guide Installation Installing the ForeSite IS Overlay The Strapped ForeSite 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 the top left of the mattress and the Foot End label is face up. ...
Page 16 ForeSite Intelligent Surface System User Guide Installation 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 bottom edge of the mattress so the overlay is fitted nicely over the mattress.
Page 17 ForeSite Intelligent Surface System User Guide Installation 5. Each corner has a strap originating from the short ends of the overlay. Grab that strap with one hand. Feed the overlay strap under any mattress-to-frame straps. XSENSOR Technology Corporation 17 of 46...
Page 18 ForeSite Intelligent Surface System User Guide Installation Lift up the long edge of the 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.
Page 19 ForeSite Intelligent Surface System User Guide Installation (Optional) If desired, roll up any excess length of strap and tuck into the nearby strap loop. Repeat Steps 5-10 for all four corner straps. XSENSOR Technology Corporation 19 of 46...
Page 20: Installing The Foresite Intelligent Mattress
ForeSite Intelligent Surface System User Guide Installation 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 that the sloped heel zone, labelled Foot End, is on the bottom half of the bed frame.
Page 21: Connecting The Power Supply
ForeSite Intelligent Surface System User Guide Installation Connecting 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 between the teeth on the brace. Push the connector into the brace until it is fully inserted in the charging port.
Page 22: Connecting The Sensor
ForeSite Intelligent Surface System User Guide Installation Connecting the Sensor The USB extension cable connects the sensor to the ForeSite IS Display Terminal. Plug the male end of the sensor USB connector into the female end of the USB extension cable.
Page 23: Securing The Usb-To-Tablet Connection
ForeSite Intelligent Surface System User Guide Installation Securing the USB-to-tablet Connection For proper strain relief on the USB cable, secure it to 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 connector. Slide the zip tie, with the teeth facing up,...
Page 24 ForeSite Intelligent Surface System User Guide Installation 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 tie end. ...
Page 25: Finish Making The Bed
ForeSite Intelligent Surface System User Guide Installation Finish Making the Bed Smooth out any wrinkles on the 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 a fitted cotton sheet.
Page 26: Maintenance And Cleaning
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 System according to the instructions in this section. XSENSOR Technology Corporation 26 of 46...
Page 27: Cleaning The Display And Connections
ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Cleaning: Cleaning the Display and Connections Caution: Any liquid that comes in contact with the external connection ports, such as the USB port, may cause corrosion and damage. Use only a soft, dry cloth to wipe the connectors.
Page 28: Cleaning And Disinfecting The Sensor Surface
ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Cleaning and Disinfecting the Sensor Surface Thoroughly clean the ForeSite IS System according to the instructions in this section. As outlined below, the sensor surface must be cleaned with two bleach-wipe-rinse cycles.
Page 29 ForeSite Intelligent Surface System User Guide Maintenance and Cleaning 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 the fabric until all visual evidence of debris is removed.
Page 30 Re-cover system with a sheet. Caution: Follow the specific EPA label contact times when using the disinfectant. Caution: Solvents containing 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: Cleaning The Top Of The System
ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Cleaning the Top of the System When there is visible soiling, clean the system as described in Cleaning and Disinfecting the Sensor Surface. If the system is about to be used for a new patient, clean with a disinfectant wipe (example CaviWipes™).
Page 32: Cleaning The Mattress Underneath The Foresite Intelligent Overlay
ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Cleaning the Mattress Underneath the ForeSite Intelligent Overlay Remove the system, or push it to the side, and wipe the mattress underneath using a disinfectant wipe (example CaviWipes™). XSENSOR Technology Corporation ...
Page 33: Cleaning The Underside Of The System
ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Cleaning the Underside of the System Wipe the entire underside of the system using a disinfectant wipe (example CaviWipes™). If working with the ForeSite Intelligent Overlay, the system can be folded in half or completely flipped over to access the underside.
Page 34: Storing The System And Display Terminal
ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Storing the System and Display Terminal If using the ForeSite Intelligent Mattress, simply unplug the USB cable from 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 on the mattress cover near the mattress indicator light.
Page 35 ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Pull upwards on the tab of the buckle to loosen the strap. Pull the strap up out of the bottom buckle slot. XSENSOR Technology Corporation 35 of 46...
Page 36 ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Pull the strap to remove it from the buckle entirely. Repeat steps 1-4 for each corner strap. Lift the straps out from under the mattress at each end of the overlay.
Page 37 ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Flip the overlay upside down and place the provided foam block at the foot end. Bring the foot edge and straps over the foam block. XSENSOR Technology Corporation 37 of 46...
Page 38 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 completely and place into the accompanying XSENSOR storage bag. XSENSOR Technology Corporation 38 of 46...
Page 39: Storage And Transport Conditions
ForeSite Intelligent Surface System User Guide Maintenance and Cleaning Storage and Transport Conditions Environmental conditions for system storage and transportation: Ambient Temperature -4 to 140˚F (-20 to 60˚C) Relative Humidity 10 to 90%, non-condensing Atmospheric Pressure 0.50 to 1.06 bar...
Page 40: End Of A System's Product Life
Maintenance and Cleaning 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 XSENSOR representative for next steps for your system. XSENSOR Technology Corporation ...
Page 41: Specifications
Pressure range 5 mmHg to 200 mmHg DISPLAY TERMINAL Note: use only with approved power supply. Display Size 26 cm Resolution 1920 x 1200 pixels Weight 1.1 kg Battery 11.1 V, 3700 mAh Bluetooth Built-in Bluetooth XSENSOR Technology Corporation 41 of 46...
Page 42 ForeSite Intelligent Surface System User Guide Specifications SYSTEM Risk Management EN ISO 14971 Electrical/ IEC 60601-1:2005/A1:2012 Edition 3.1 Mechanical Safety Electromagnetic IEC 60601-1-2:2014 Edition 4.0 Compatibility XSENSOR Technology Corporation 42 of 46...
Page 43: Compliance With Emission And Immunity Standards
ISO 17025 General requirements for the competence of testing and calibration laboratories *XSENSOR declares that the ForeSite IS complies with the European Communities Council Medical Device Directive 93/42/EEC amended by 2007/47/EC. This declaration will be deemed invalid should any XSENSOR Technology Corporation ...
Page 44 ForeSite Intelligent Surface System User Guide Specifications unauthorized modifications be made to the systems. Follow this User Guide when setting-up and operating the system. Emissions Test Compliance Electromagnetic Environment – Guidance RF Emissions Group 1 The ForeSite IS System uses RF energy only for its internal function.
Page 45 ForeSite Intelligent Surface System User Guide Specifications IEC 60601-1-2:2014 Immunity Test IEC 60601 Compliance Level Electromagnetic Environment – Guidance Test Level Conducted RF 10 V/m, 1 kHz 10 V/m, 1 kHz AM Portable and mobile RF communications IEC 61000-4-6 AM at 80%...
Page 46: Contact Information
Darling Park, Tower II, Level 20 Sydney, NSW, 2000 Australia Tel: +61 2 9006 1662 Web: emergogroup.com XSENSOR Authorized Representative in the UK: Advena Ltd. Pure Offices, Plato Close, Tachbrook Park, Warwick, CV34 6WE United Kingdom Tel: +44 1926 800153 Web: advenamedical.com...
Page 47 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, including the right to reproduce this user guide or portions thereof in any form whatsoever.