Wellsense M.A.P WS-100 User manual

Model WS-100
User Guide
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Copyright © 2013 Wellsense USA, Inc. All rights reserved.
Publication Catalog No.: WS-UG-00002-08
Revision Date: January 2015
Wellsense, M.A.P™ and the Wellsense logo are trademarks and/or registered trademarks of
Wellsense USA, Inc.
Wellsense USA, Inc. reserves the right to make changes without notice to its products or
specifications to improve performance, reliability or manufacturability.
All information supplied by Wellsense USA, Inc. is believed to be accurate and reliable. However,
Wellsense USA, Inc. assumes no responsibility for its use. No license is hereby granted by its
implication or otherwise under any patent or patent rights of Wellsense USA, Inc.
This document, in part or entirety, is not to be produced, reproduced or transmitted in any form
or by any means, electronic or mechanical, for any purpose, without the express written
permission of Wellsense USA, Inc.
Wellsense USA, Inc. has patents and pending patent applications, trademarks, copyrights,
and/or other intellectual property rights covering the subject matter in this document. Providing
of this document does not give any license to these patents, trademarks, copyrights, and/or
other intellectual property rights unless otherwise expressly provided in any written agreement
from Wellsense USA, Inc.
Contact Wellsense Service for customer support and technical services:
Wellsense USA, Inc.
2416 21st Avenue South
Suite 203
Nashville, TN 37212
USA
1-888-335-0995
Email:[email protected]
web:www.themapsystem.com
Obeliss.a.
Boulevard General Wahis 53
1030 Brussels, BELGIUM
Tel: + (32)2. 732.59.54
Fax: + (32)2.732.60.03
E-Mail: [e-mail]
Wellsense Technologies Ltd
Communication Center
Neve-Ilan
90850,Israel
Tel:+ 972-26470703
Fax: [phone]

Tables and Contents
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Table of Contents
Introduction ..............................................................................................................................................6
Safety and Regulatory Issues .......................................................................................................................... 7
System Description........................................................................................................................................ 11
Overall Description....................................................................................................................... 11
Components ................................................................................................................................. 11
System Setup and Installation....................................................................................................................... 13
Unpack the System.......................................................................................................................13
Install the Pressure Sensing Mat (PSM) .......................................................................................14
Installing the Coverlet ..................................................................................................................17
Placing the System Control Unit (SCU) ........................................................................................18
Nurse Call Interface......................................................................................................................19
Clinical Use .................................................................................................................................................... 20
Initiating Operation...................................................................................................................... 20
Patient Monitoring and Repositioning.........................................................................................24
Repositioning Schedule Editing.................................................................................................... 27
System Shutdown ........................................................................................................................28
Troubleshooting............................................................................................................................................. 29
Maintenance.................................................................................................................................................. 31
Cleaning and Disinfecting the System..........................................................................................31
Storage.......................................................................................................................................... 33
System Specifications.................................................................................................................................... 34
Warranty........................................................................................................................................................ 42

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Abbreviations and Acronyms
Abbreviation
Description
'
Feet
"
Inches
A
Amperes
HWC
Hardware Controller
SCU
System Control Unit
PSM
Pressure Sensing Mat
°C
Degrees Centigrade
°F
Degrees Fahrenheit
Hz
Hertz
Kg.
Kilograms
Lbs.
Pounds
cm
Centimeters
mm
Millimeters
mmHg
Millimeters of Mercury
VAC
Volts, Alternating Current
VDC
Volts, Direct Current

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Symbols Used in the System
Symbol
Description
EMC- 60601 certification
Certified to CSA Std. C22.2 No 601.1
Conforms to UL Std 60601-1, Certification number:4003520
Defibrillator compliance declaration according to IEC 60601-1:
Exposure of the M.A.PTM to the defibrillation voltage, emits no risk to
system which continues to perform its intended function
CE mark. European Conformity
Federal Communications Commission approval number:U9R-W2SW001
Consult Instructions For Use
IMPORTANT: Read and understand user guide and all precautions
before using
Manufacturer address
Manufacturing date
Manufacturer's Batch Code
Serial Number
Reference Number
Device storage conditions limits
Device inlet voltage
Waste of Electrical and Electronic Equipment (WEEE) Compliance
Symbol
Type BF Equipment
Do Not Wash: See user guide for proper cleaning procedures
Do Not Iron
Do Not Dry Clean

Introduction
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Introduction
The M.A.P™ is the first-ever bedside pressure mapping system. Used seamlessly on any
existing bed, M.A.P allows caregivers to place and position patients and residents using
actual pressure distribution data.
The M.A.P assists caregivers in providing optimal comfort to patients while assuring
that proper off-loading has been achieved. As an educational tool that can improve
compliance, patients learn the relationship between proper off-loading and prevention.
M.A.P can assist in proper surface selection and detection of malfunctioning beds and
mattresses.
This user guide explains the safety requirements and how to set up and operate the
system.
Caution
M.A.P™ is a supportive tool and is not a substitute for maintaining a
routine of visual monitoring and repositioning protocols.
Pressure Sensing Mat (PSM) and Coverlet need to be covered with a
clean bed sheet while in use. Patients should not be placed directly on
PSM or Coverlet.

Safety and Regulatory
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Safety and Regulatory Issues
Overall System
 Before you start, be sure to read this guide to become familiar with all safety requirements
and operating procedures.
 Any modification made to the equipment, or connecting components from other
manufacturers voids all service or replacement warranties and poses a potential safety
threat to both operators and patients.
 Median/divider placed between the patient and the bed linen that is not provided or
recommended by Wellsense (such as pillow, towel or any kind of pressure distribution aid
or for other purposes) might reduce the accuracy of pressure measurements and display.
 Portable and mobile RF communications equipment can affect medical electrical
equipment. Interference may occur in the vicinity of the system.
 The system must be connected to a 3-pin grounded power outlet with the supplied power
cable.
 Do not place any electronic devices/equipment, such as mobile phones or computers, on the
Pressure Sensing Mat (PSM) or coverlet. Please make sure there are no power supply boxes
or electrical cables on the PSM or coverlet.
 Sterilization by heat, gas, radiation or any harsh materials other than the recommended
method voids all service or replacement warranties.
 The maximum tested patient weight to ensure accurate measurements and the product's
durability is 250 kg. / 550 lbs.
 Maximum patient height recommended for adequate monitoring purposes is 194 cm / 6' 4".
 Report and remove from service any M.A.P™ that is defective or damaged, including:
 Torn or damaged PSM.
 A broken plastic part.
 A ripped or frayed electrical cable.
 A malfunctioning LCD screen.
 Unclear or broken display of pressure map image on the LCD screen.

Safety and Regulatory
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Touch Screen
Use only fingertips to operate the touch screen. Avoid using fingernails, pens or any
sharp objects that might damage the screen.
Pressure Sensing Mat (PSM)
 Clean the PSM according to the instructions given in this guide.
 Always wear gloves while cleaning or relocating the pressure sensing mat. Ensure
the power supply cable is disconnected from the electrical outlet prior to cleaning
the PSM.
 Ensure the hardware controller is well connected to its docking station prior to
cleaning the PSM, in order to avoid any ingress of liquid to the electrical
components.
 Place a Coverlet on top of the PSM and under the bed linens. Coverlets can be
purchased from Wellsense. Please refer to the installation and maintenance
instructions.
 Ensure a bed sheet is placed between the patient and the PSM/Coverlet.
Storage
 Once cleaned and removed from a bed, assure the PSM is stored in a clean
environment.
 Ensure that the PSM is as flat as possible during storage and avoid wrinkles.
 Ensure System Control Unit is adequately protected while not in use.
Electrical and Mechanical Safety
 The system does not contain any self-serviceable parts. Never attempt to open or
remove the exterior covers of the hardware components or of the PSM. Removal of
the covers can create a safety hazard and voids the warranty.
 The system is grounded through the grounding conductor in the power cable. This
protective grounding is essential for safe operation.
 An independent electronic circuit stops the system in case of a short circuit.

Safety and Regulatory
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Safety and Regulatory
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Fire Hazards
Do not operate the M.A.P™ in the presence of explosive or highly flammable materials
like alcohol, methanol, acetone, and the like.
If alcohol is used for cleaning and disinfecting, or if alcohol is an ingredient in the
approved cleaning materials, it must be allowed to dry thoroughly before the unit is
placed in use.