Wellsense M.A.P WS-100 User manual

Model WS-100
User Guide
Scan the QR code to watch the M.A.P™

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

Tables and Contents
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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.

System Set Up and Installation
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System Description
Overall Description
The M.A.P™ is the first technology to provide real-time on-going monitoring and display of all
pressure levels.
The M.A.P images and monitors the pressure created between the patient and the surface,
allowing health care providers to visualize high pressure spots that may become pressure
ulcers. Caregivers can use the M.A.P image to effectively reposition the patient to redistribute
high pressures.
The M.A.P technology can also remind caregivers to reposition the patient at regular intervals,
which is another key practice for preventing pressure ulcers.
The M.A.P includes two main parts: (1) The Pressure Sensing Mat (PSM), which is placed on
the bed under the patient, connects through a cable to the (2) System Control Unit (SCU) which
is mounted on the foot of the bed where it can be easily seen by caregivers. The System Control
Unit contains the controls for the system and displays the pressure image.
Components
Figure 1: M.A.P™ Inter-Connection Layout
Pressure Sensing Mat
and attached docking
station, including a set
of 5 stretchable straps
System Control Unit
(SCU)
Hardware Controller
(HWC)
Power supply module

System Set Up and Installation
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The PSM with its built-in docking station is designed to be cleaned and disinfected between
patients. For accurate measurements and utilization of the system's full potential, Wellsense
strongly recommends not using it beyond its warranty period. Please read the warranty
document included in this guide.
Caution
Only clean the PSM with the Hardware Controller connected. The exposed
electronic components of the hardware controller and the docking station
may be irreparably damaged by the ingress of any liquid.
Note
Any damage to the package or to the system found prior to opening the
package should be reported to a Wellsense representative.

System Set Up and Installation
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System Setup and Installation
This section explains how to install M.A.PTM and prepare it for regular use.
Unpack the System
Remove all of the components delivered in the shipping box.
The M.A.P is shipped with the following components (see Figure 2).
1Pressure Sensing Mat (PSM) with docking station (folded)
2System Control Unit (SCU)
3SCU mounting hook
4Hardware controller (HWC)&its connected Power supply module
5Power Cord
6Coverlet (if purchased from Wellsense)
7Three (3) longer horizontal Stretchable Straps (optional use).

System Set Up and Installation
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Install the Pressure Sensing Mat (PSM)
Caution
The PSM should only be installed onto an empty bed. Attempting to install
the PSM on a bed which contains a patient could lead to patient discomfort
or injury.
1. Installing the PSM does not require the mattress to be removed from the bed.
However, it should be slightly lifted at each end to attach the PSM to the mattress.
2. Unfold the pressure sensing mat and unhook the provided set of straps. Level the
pressure sensing mat over the mattress.
Figure 2: Installing the PSM
Note
Ensure that the docking station attached to the PSM is positioned outwards
and at the foot of the bed.
3. Align the corners of the PSM with the corners of the mattress. Fold the corner tabs of
the PSM onto the mattress sides.

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Figure 3: Installing the PSM –smoothing the corners
4. Flatten the PSM as much as possible to avoid folds or wrinkles.
5. Attach the PSM with the provided straps (2 vertical and 3 horizontal straps) to the
mattress only and not to the bed frame.
6. For ease of use, the stretchable straps can be attached/detached from both ends of the
PSM with the designated buckles.
Figure 4: Attaching the PSM straps
7. Ensure all straps are securely attached to the PSM as presented in the following
figure:
Figure 5: Correct installation of PSM straps configuration
 Strap extensions are available from Wellsense for use on oversized or
bariatric mattresses.
 Ensure PSM is smooth and does not have wrinkles or folds before placing
the bed sheet on top.
 Never leave unbuckled straps. The PSM should always be connected to
the mattress to ensure patients’ comfort and correct pressure monitoring.

System Set Up and Installation
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8. Press the hardware controller to the docking station until both tabs are engaged to
ensure proper connection to the PSM. The logo on the HWC box should be facing
up.
Note
Improper connection of PSM to the controller may result in a Pressure
Sensing Mat failure notification or an incorrect pressure image.
Figure 6: Attaching the HWC to the PSM’s docking station
Caution
Patients should not be placed directly on the PSM. The PSM should always be
covered with a Coverlet and a clean bed sheet while in use.

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Installing the Coverlet
Place a Coverlet on top of the PSM. Coverlets can be purchased from Wellsense separately. The
Coverlet may lengthen the useful life of your PSM and allows for easier patient movement on
the support surface. The Coverlet is placed directly over the PSM, and the bed sheet placed
over the Coverlet.
1. The Coverlet straps are designed such that the mattress does not need to be
removed from the bed for installation. However, it should be slightly lifted at each
end.
2. Unfold the Coverlet and unhook the straps. Place the Coverlet over the PSM and
mattress. Ensure the Wellsense logo is facing upwards and is located at the foot of
the bed as presented in the below figure:
Figure 7: Placing the Coverlet on the bed
3. Ensure all four (4) diagonal straps are securely attached to the corners of the
mattress over the PSM as presented in the following figure:
Figure 8: Attaching the Coverlet straps
4. Ensure the Coverlet is smooth and does not have wrinkles or folds before placing
the bed sheet on top.
5. Please refer to the cleaning and disinfecting section of this document for complete
cleaning instructions.

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Placing the System Control Unit (SCU)
The SCU should be mounted at the foot of the bed for easy visualization and access. The SCU
fits onto the supplied mounting hook which is positioned on the footrail of the bed.
1. Place the mounting hook to the footrail. Assure it is firmly in place and stable.
2. Attach the SCU to the mounting hook by sliding the top of the hook through the
opening at the top of the SCU.
Figure 9: Placing the System Control Unit at the foot of the bed
3. Properly route the cables for maximum cord length while avoiding pinch points or
entanglement.
4. Once the system is assembled correctly, connect the power cable to the AC power
outlet. Ensure all cables are safely routed.
Note
Always mount the SCU at the foot of the bed. When the SCU is mounted at
the head of the bed the movement of the bed may cause damage to the
cables.

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Nurse Call Interface
The M.A.P™ can be connected to interact with a Nurse Call System via a normally open or
normally closed interface connection. This interface will forward the pre-set system notifications
to the nurse call system.
The default factory settings allow for a normally open connection. In order to modify the preset
configuration, contact Wellsense support.
The system uses a standard, 1/8 to 1/4 inch cable connector. This type of connector is the most
common and allows for maximum compatibility with most nurse call systems in use.
Figure 10: Nurse Call System Cable Connection Port
For assistance with the nurse call system interface, contact the facility’s biomedical engineering
department or contact Wellsense.
Note
Technical requirements may vary from one nurse call system to another. For
best compatibility, verify the requirements of your specific nurse call system.

Troubleshooting
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Clinical Use
Initiating Operation
1. Press the on/off button located on the bottom of the SCU. The unit will take few
seconds to power up, push the button only once.
The system will initialize and begin an automatic routine of self-testing. During this
routine, a progress bar will be displayed.
Figure 11: Powering up of the M.A.P™
Note
When the power cord is unplugged from the socket and then reconnected,
the system automatically powers itself up without pressing the on button
again.
If the power cord is disconnected without turning the unit off first (disorderly
shutdown), the system will take longer to boot up.