Xsensor ForeSite SS User manual

User Guide

1
ForeSite SS User Guide Revision
All trademarks appearing in this document belong to XSENSOR
Technology Corporaon.
© XSENSOR Technology Corporaon. All rights reserved.
The XSENSOR Pressure Imaging System is protected by copyright
law. Unauthorized reproducon or redistribuon of XSENSOR
soware is prohibited. No part of this document may be
reproduced or transmied in any form without the express
wrien permission of XSENSOR Technology Corporaon.
ASY-05-00005-02

1
TABLE OF CONTENTS
INTRODUCTION 1
The ForeSite SS System 3
Overview 3
Intended Use 3
Product Compliance 4
Safety Standards 4
Emission & Immunity Standards 5
 Warnings&Cauons 11
FORESITE SS HARDWARE 15
ForeSite SS Tablet Wireless System 17
ForeSite SS Tablet System 21
 DisplayTabletSpecicaons 27
Maintenance 30
Storage & Transport 30
Cleaning 32
Cleanable Sensor Instrucons 33
FORESITE SS SOFTWARE 37
Introducon 39
 QuickStart 39
User Roles & Security 41
 AdministraveSengs 41
 StandardSengs 45
Client Management 48
 PressureImaging 49
Gallery Management 51
APPENDIXES 55
 Appendix1-Troubleshoong 56
Appendix 2 - The Desktop System 58
 Appendix3-ContactInformaon 64

Introducon
The ForeSite SS System 3
Overview 3
Intended Use 3
Product Compliance 4
Safety Standards 4
Emission & Immunity Standards 5
Warnings&Cauons 11

Introducon 3
The ForeSite SS System: Overview
Thank you for purchasing the ForeSite SS Pressure Imaging System!
The ForeSite SS sensor is embedded with thousands of sensor cells that
connuously measure the level of pressure between two solid objects.
For clinical purposes, this may be the level of pressure between a
wheelchair and a client’s body surface. The sensor connects to a touch
screen tablet that displays live pressure informaon and stascs on
a colour-coded scale. The resulng pressure images may be rotated,
captured as snapshots, recorded as a series of frames, and even
displayed in 3D.
ForeSite SS is designed to be intuive and user-friendly in an eort
to help wheelchair seang professionals make more informed clinical
decisions
Wheelchair users are at an increased risk of developing pressure ulcers
which can form when muscles and so ssue press against surfaces
such as a chair or a bed. As such, preventave measures must be taken
in order to reduce these risks. ForeSite SS provides clinicians with
the tools they need to help their clients reduce the risk of developing
pressure ulcers. By ulizing ForeSite SS, clinicians are able to create an
image of the relave pressure distribuon over a surface. The dynamic
pressure images then allow them to evaluate the pressure distribuon,
and, if necessary, take appropriate measures to enhance the pressure
distribuon for that parcular surface.
ForeSite SS is calibrated at the factory to improve the overall accuracy
of the pressure distribuon images. However, the system is not
intended to replace current best pracces for prevenon of pressure
ulcers. It is intended to provide addional monitoring and data
collecon while standard monitoring techniques and turn schedules are
maintained.
The ForeSite SS System: Intended Use
!

Introducon4
Product Compliance: Safety Standards
The XSENSOR Pressure Imaging System complies with the following
standards:
√IEC 60601-1:2005, CSA C22.2 No. 60601-1:2008, ANSI/AAMI ES 60601-1/
A2:2010, UL 60601-1:2003
√Mode of Operaon
√Class I Medical Equipment
√Type B Applied Part. Only the sensor(s) touch the paent in normal use.
The ForeSite SS is intended for use by healthcare professionals only.
ForeSite SS must be installed and used as described in this user manual.
This system is designed in compliance with medical safety standards and is
intended for the use of clinicians only. It is not recommended for private use
or client use without the assistance of a trained medical professional. There
are no known contraindicaons to its use. For any quesons or concerns in
regards to the safety of this product, do not hesitate to contact XSENSOR
(see Appendix 4).

Introducon 5
Product Compliance:
Emission & Immunity Standards
The ForeSite SS is a class A digital device suitable for business, industrial and
commercial environments. It is not intended for residenal use. The ForeSite
SS may cause radio interference or may disrupt the operaon of nearby
equipment. Portable and mobile RF communicaons equipment can also
aect ForeSite SS. It may be necessary to take migaon measures, such as
reorienng or relocang the equipment or shielding the locaon.
The ForeSite SS should not be used adjacent to or stacked with other
equipment. If adjacent or stacked operaon is necessary, the Pressure
Imaging System should be observed to verify normal operaon in the
conguraon in which it will be used.
Use of accessories and cables other than those provided by XSENSOR may
result in increased emissions or decreased immunity.
ForeSite SS complies with Part 15 of the FCC Rules. Operaon is subject to the
following condions: (1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference
that may cause undesired operaon.
Standards Compliance:
√EN 60601-1-2:2007 (Ed3.0) Medical Electrical Equipment – Part 1:
General Requirements for Safety 2. Collateral Standard: Electromagnec
Compability (Non-life-supporng, Group 1, Class A Equipment)
√FCC 15.107/CISPR 11 (Class A) Conducted Emissions
√FCC 15.109/CISPR 11 (Class A) Radiated Emissions
√Industry Canada ICES-003(A)/NMB-3(A) Compliant
√IEC 61000-3-2:2005 Harmonics Emissions
√IEC 61000-3-3:2008 Flicker Emissions
√IEC 61000-4-2:2008 Electrostac Discharge
√IEC 61000-4-3:2008 Radiated Suscepbility
√IEC 61000-4-4:2007 Electrical Fast Transients
√IEC 61000-4-5:2005 Surge Suscepbility
√IEC 61000-4-6:2006 Conducted Suscepbility
√IEC 61000-4-8:2001 Magnec Suscepbility
√IEC 61000-4-11:2007 Dips & Interrupts

Introducon6
Guidanceandmanufacturer’sdeclaraon–
electromagnecemissions
The ForeSite SS system is intended for use in the electromagnec
environments specied below. ForeSite SS system users should ensure
that it is used in such an environment.
Emissions Test Compliance Electromagnec
Environment Guidance
RF emissions CISPR 11 Group 1 The ForeSite SS system
uses RF energy only for
its internal funcon.
Therefore, its RF
emissions are very low
and are not likely to
cause any interference
in the nearby electronic
equipment.
RF emissions CISPR 11 Class A The ForeSite SS system
is suitable for use in all
establishments other
than domesc and those
directly connected to the
public lowvoltage power
supply network that
supplies buildings used
for domesc purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuaons/
icker emissions
IEC 61000-3-3
Complies
Recommendedseparaondistancesbetween
portableandmobileRFcommunicaonsequipmentandtheForeSiteSS
The ForeSite SS is intended for use in an electromagnec environment in which
radiated RF disturbances are controlled. The customer or the user of the ForeSite SS
can help prevent electromagnec interference by maintaining a minimum distance
between portable and mobile RF communicaons equipment (transmiers) and the
ForeSite SS as recommended below, according to the maximum output power of the
communicaons equipment.
Rated maximum
output power
of transmier
W
Separaon distance according to frequency of transmier
M
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
11.17 1.17 2.34
10 3.69 3.69 7.38

Introducon 7
Recommendedseparaondistancesbetween
portableandmobileRFcommunicaonsequipmentandtheForeSiteSS
The ForeSite SS is intended for use in an electromagnec environment in which
radiated RF disturbances are controlled. The customer or the user of the ForeSite SS
can help prevent electromagnec interference by maintaining a minimum distance
between portable and mobile RF communicaons equipment (transmiers) and the
ForeSite SS as recommended below, according to the maximum output power of the
communicaons equipment.
Rated maximum
output power
of transmier
W
Separaon distance according to frequency of transmier
M
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
11.17 1.17 2.34
10 3.69 3.69 7.38

Introducon8
Theequipmentisintendedforuseintheelectromagnecenvironment
speciedbelow.Thecustomerortheuseroftheequipmentshould
assurethatitisusedinsuchanenvironment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnec environment - guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3 Vrms
150 kHz
to 80 MHz
3 V/m 80
MHz to
2,5 GHz
3 V
3 V/m
Portable and mobile RF communicaons
equipment should be used no closer to any part
of the equipment including cables, than the
recommended separaon distance calculated
from the equaon applicable to the frequency
of the transmier.
Recommended separaon distance
where P is the maximum output power rang
of the transmier in was (W) according to
the transmier manufacturer and d is the
recommended separaon distance in meters
(m). Field strengths from xed RF transmiers,
as determined by an electromagnec site
surveya should be less than the compliance level
in each frequency rangeb
Interference may occur in the vicinity of known
RF transming devices and equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situaons. Electromagnec ropagaon is aected
by absorpon and reecon from structures, objects and people.
a) Field strengths from xed transmiers, such as base staons for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theorecally with accuracy. To assess the electromagnec
environment due to xed RF transmiers, an electromagnec site survey should be
considered. If the measured eld strength in the locaon in which the equipment is used
exceeds the applicable RF compliance level above, the equipment should be observed to
verify normal operaon. If abnormal performance is observed, addional measures may be
necessary, such as re-orienng or relocang the equipment
b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

Introducon 9
Theequipmentisintendedforuseintheelectromagnecenvironment
speciedbelow.ThecustomerortheuseroftheEquipmentshould
assurethatitisusedinsuchanenvironment.
Immunity test IEC 60601 test
level
Compliance level Electromagnec
environment –
guidance
Electrostac
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be
wood, concrete
or ceramic
le. If oors
are covered
with synthec
material, the
relave humidity
should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines ±1
kV for input/
output
lines
±2 kV for power
supply lines ±1
kV for input/
output lines
Mains power
quality should be
that of a typical
commercial
or hospital
environment.
Surge IEC 61000-
4-5
±1 kV line(s) to
line(s) ±2 kV
line(s) to earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Mains power
quality should be
that of a typical
commercial
or hospital
environment.

Introducon10
Voltage
dips, short
interrupons
and voltage
variaons on
power supply
input lines IEC
61000-4-11
UT = 230 Vac
<5 % UT (>95 %
dip in UT) for 0,5
cycle 40 % UT
(60 % dip in UT)
for 5 cycles 70 %
UT (30 % dip in
UT) for 25 cycles
<5 % UT (>95 %
dip in UT) for
5 sec
<5 % UT (>95 %
dip in UT) for 0,5
cycle 40 % UT
(60 % dip in UT)
for 5 cycles 70 %
UT (30 % dip in
UT) for 25 cycles
<5 % UT (>95 %
dip in UT) for
5 sec
Mains power
quality should be
that of a typical
commercial
or hospital
environment. If
the user of the
equipment
requires
connued
operaon during
power mains
interrupons, it
is recommended
that the
equipment
be powered
from an
uninterrupble
power supply or
a baery.
Power frequency
(50 Hz) magnec
eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency
magnec elds
should be
at levels
characterisc of
a typical locaon
in a typical
commercial or
hospital
environment.

Introducon 11
Warnings&Cauons
!
The ForeSite SS System has been designed and tested in accordance with
the previously menoned safety standards. To ensure safe use of the
product, follow all safety and operang instrucons in this guide. At the
end of the System product life, please contact XSENSOR for safe disposal
instrucons (see Appendix 4).
1. Warning: Use only approved power supplies (SINPRO part number
HPU32A-105 and Glob Tek part number WR9QA1200MICB-N-M)
with the ForeSite SS System. Power supplies specied are part of
the equipment. Do not posion any part of the equipment to keep it
from disconnecng from the mains, should the need arise.
2. Warnings: ForeSite SS should only be congured as indicated in the
hardware secon of the User Guide. Modicaon of this equipment
is prohibited.
3. Warning: The ForeSite SS Sensor should be cleaned between each
use. Unplug all product components from the wall outlet before
cleaning. See the Maintenance secon of the User Guide for
informaon on cleaning.
4. Warning: The ForeSite SS System is not intended for long term use.
5. Warning: The ForeSite SS System is intended for use by health care
professionals only.
6. Warning: To reduce risk of electric shock, connect the Magtech
26-2704 to supply mains with protecve earth. Where available,
connect the equipment to a receptacle marked “Hospital Only,”
“Hospital Grade,” or an equivalent.
7. Warning: Always completely disconnect the power cord from
your chassis whenever you work with the hardware. Do not make
connecons while the power is on. Sensive electronic components
can be damaged by sudden power surges.
8. Warning: Do not connect any external accessories, including
computers, cables, or peripherals, to the ForeSite SS Display Tablet
input/output ports (USB, Ethernet, and HDMI) which is part of a
wired (USB Sensor Pack) system during client pressure monitoring.
If using the ForeSite SS Tablet Wireless System (Wireless Sensor
Pack), please note that the ForeSite SS tablet is no longer medically
compliant when connected to any external accessory. As such,
please ensure the tablet and any accessory equipment are kept at
least 1.83m (6’) away from the subject when connected.

Introducon12
9. Warning: Do not use the ForeSite SS System if any of the cables
to and from any of the enclosed units are damaged or frayed. This
includes the power supply and Sensor USB cable. Contact XSENSOR
to replace damaged cables (see Appendix 4 of the User Guide).
10. Warning: Do not use the ForeSite SS System if the Sensor pad’s
covering material is visibly damaged or punctured. Ensure that
clients making contact with the Sensor do not have sharp objects
on their person, and that no sharp objects make contact with the
Sensor, as it may puncture the Sensor during use. Contact XSENSOR
for a replacement Sensor if it becomes damaged; do not aempt to
repair with cheap materials such as tape or glue.
11. Warning: Do not use the equipment in the presence of a ammable
anesthec mixture with air, oxygen, or nitrous oxide.
12. Warning: Do not use the ForeSite SS Sensor to li the client or to
help remove the client from a seated posion.
13. Warning: ForeSite SS Tablet may become hot with extended
use in a hot environment. Handle with care and avoid contact with
hot surfaces. Do not place tablet on any body surface. Place on a
hard surface and do not impede airow.
14. Warning: Always lay the Tablet on a at, sturdy surface when not in
use to prevent damages from falling.
15. Warning: Do not allow clients to handle the Tablet or Sensor
cables; these should be handled only by registered health care
professionals.
16. Warning: Do not aempt to service this product by yourself, as
opening or removing covers may expose you to dangerous voltage
points or other risks and will void the warranty. Refer all servicing
to qualied service personnel.
17. Warning: Do not touch the LCD panel surface with sharp or hard
objects.
18. Warning: The ForeSite SS Sensor is not intended for direct contact
with the client’s skin and should be covered with a sheet or
clothing.
19. Warning: The Sensor is not debrillator-proof.
20. Cauon: Administrave opons and sengs must be reviewed and
selected by a qualied medical praconer.

Introducon 13
21. Cauon: Never intenonally expose the Sensor pad to moisture
besides the specied cleaning agents. Refer to the Maintenance
secon of the User Guide for more informaon on cleaning.
22. Cauon: For the Sensor, labeling and grid marks must face towards
the client’s body; do not use the ip side of the Sensor against a
client’s body.
23. Cauon: The ForeSite SS System is designed for indoor use only.
24. Cauon:For informaon regarding the safe disposal of the ForeSite
SS Display Tablet or Sensor at the end of product life, contact a local
XSENSOR representave or XSENSOR directly (see Appendix 4 of the
User Guide).
25. Cauon: Only use the cables provided with the ForeSite SS System.
26. Cauon: Ensure power cords do not trail on the ground, to avoid
tripping hazards.
27. Cauon: Avoid damage to the Display Tablet by never seng or
resng another object on it while it is not in use.
If any of these warnings or cauons are unclear, do not hesitate to contact
XSENSOR immediately for more informaon (see Appendix 4).

Note: For informaon
on using ForeSite SS
Desktop Systems,
please see Appendix#2.

ForeSite SS
Hardware
ForeSite SS Tablet Wireless System 17
ForeSite SS Tablet System 21
DisplayTabletSpecicaons 27
PowerSupplySpecicaons 29
X4Lithium-IonBaery 29
Specicaons
Maintenance 30
Storage & Transport 30
Cleaning 32
Cleanable Sensor Instrucons 33
ForeSite SS Label Symbols 35
Note: For informaon
on using ForeSite SS
Desktop Systems,
please see Appendix#2.

ForeSite SS Hardware16