Thought Technology eVu TPS User manual

eVu TPS® User Guide
2
Thought Technology Ltd.
8205 Montreal/Toronto Blvd., Suite 223,
Montreal West, Quebec, Canada H4X 1N1
[phone]
[e-mail]
Product
Name:
eVu TPS
T4500
EMERGO EUROPE
Molens traat 15, 2513 BH
The Hague, The Netherlands

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Table of Contents
About this User Guide......................................................... 4
Audience ......................................................................... 4
Labeling Symbols ............................................................. 5
Product Description ............................................................ 7
Overview ......................................................................... 7
Warnings and Precautions ................................................ 14
Maintenance and Care ...................................................... 18
Instructions for Use........................................................... 20
Wearing the Device ....................................................... 20
Troubleshooting................................................................ 25
Technical Support and Contacts........................................ 27
Placing Orders and Technical Support ........................... 27
Warranty ....................................................................... 28
Disposal ......................................................................... 29
Returning Equipment .................................................... 29
Service Return Form ......................................................... 32
Manual No. SA4504 (June 2016)
© 2016 copyright Thought Technology Ltd. All rights reserved.

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About this User Guide
Audience
This User Guide is intended for eVu TPS® users
(licensed health care practitioners) who are trained
and qualified in Biofeedback techniques. Experience
in this field and knowledge of commonly used
equipment and standard practices are
prerequisites.
The User Guide includes a technical description of
system parts and accessories, and instructions
about system setup and maintenance.
It also includes important information about the
safe and effective use of the system with
designated software which may be downloaded
from the company’s web site at
www.evutps.com.

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Labeling Symbols
Operating instructions [consult
accompanying documents]
Caution, consult accompanying
documents
[Enter / Exit] Stand-by mode
Type BF Applied Parts
Keep dry
Keep away from sunlight
Fragile, handle with care
Waste Electrical Items bearing this
symbol must not be disposed of with
general household waste. Dispose
according to local recycling initiatives.

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Indicates that the product is
manufactured in conformity with the
Medical Device Directive and other
applicable European Community
directives.
Authorized Representative in the
European Community
Manufacturer
Date of manufacture
Catalogue number
Warning! Not suitable for children
under 3 years

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Product Description
Overview
The eVu TPS® system contains a miniaturized self-
contained battery-operated finger-worn
biofeedback device. The TPS senses skin
conductance, skin temperature, and heart rate by
photoplethysmography, transmitting these signals
wirelessly using Bluetooth. The TPS works with a
software app on a mobile device to display the
signal.
INTENDED PURPOSE
•
Biofeedback and relaxation.
•
The device is not intended to measure
quantitatively the value of physiological
parameters; measurements are relative to
each other, indicating short-term trends rather
than absolute values.
CONTRAINDICATIONS
•None.

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OPERATOR PROFILE
•This device is intended to be operated by adult
patients only.
•Pediatric use only under supervision of adult /
healthcare provider.
CAUTION
•
US Federal Law restricts this device to sale by
or on order of a licensed health care
practitioner.
PRODUCT CONTENTS
•
1 x SA4500 TPS
•
1 x SA4505 Strap
•
1 x SA45XX Charger (Medical Grade Universal
Power Supply / AC Power Adapter)
•
1 x MI1134 Carrying case, Black
Note: The usage of the device requires an Android app
which can be found at the following link
www.evutps.com. The app runs on an Android
platform using Version 4.4 or above. The
recommended tablet / phone screen size is
from 4.5 to 9.7 inch.

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TECHNICAL SPECIFICATIONS
Weight
Approx. 20g (without the Charger)
TPS size
Approx. 50mm x 30mm x 20mm
Li-ion Polymer
Battery
Nominal
voltage
3.7V
Skin conductance
measurement
Range 0 – 30 uS
Temperature
measurement
Range 10 – 40 ˚C
Accelerometer
Number of
Axes
3 (X, Y, Z)
Wireless
communication
Bluetooth Classic
OPERATING ENVIRONMENTAL CONDITIONS
•Standard EN/IEC 60601-1-11
•Temperature +5˚C – +40˚C
•Relative
humidity
15 % – 93% (non-
condensing)
•Atmospheric
pressure
700 hPa – 1060 hPa

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TRANSPORT AND STORAGE
ENVIRONMENTAL CONDITIONS
•Standard EN/IEC 60601-1-11
•Store in its original case.
•Temperature
and relative
humidity
-25˚C without relative
humidity control
+70˚C at relative humidity
up to 93%, non-condensing
•Atmospheric
pressure 700 hPa – 1060 hPa
ELECTRICAL SAFETY SPECIFICATIONS
•Standard EN/IEC 60601-1 and
IEC60601-1-11
•Type of
protection
against electric
shock
Internally powered
equipment
CLASS II (when connected to
Charger)
•Degree of
protection
against electric
shock
Type BF Applied Parts
(TPS with built-in sensor)

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•Mode of
operation
Continuous
•Degree of
protection
against ingress
of water
IPX0 (no protection)
•Protection
against ignition
of flammable
anaesthetic
mixtures
EQUIPMENT NOT SUITABLE
FOR USE IN THE PRESENCE
OF FLAMMABLE
ANAESTHETIC MIXTURE
WITH AIR OR WITH OXYZEN
OR NITROUS OXIDE
•Charger Power
Rating (Medical
Grade Universal
Power Supply /
AC Power
Adapter)
UL/IEC 60601-1
Input: 100-240Vac,
60/50Hz, 0.6A
Output: 5Vdc, 1.2A
ELECTROMAGNETIC COMPATIBILITY
•Standard EN/IEC 60601-1-2

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Guidance and manufacturer's declaration –
Electromagnetic emissions
The eVu TPS is intended f or use in the electromagnetic environment
specified below. The customer or the user of the eVu TPS should assure
that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The eVu TPS uses RF energy only
for its internal function. Therefore,
its RF emissions are very low and
are not likely to cause any
interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B The eVu TPS is suitable for use in
all establishments, including
domestic establishments and
those directly connected to the
public low -voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class B
Voltage
fluctuations
flicker
emissions
IEC 61000-3-3
Complies

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Guidance and manufacturer’s declaration –
electromagnetic immunity
The eVu TPS is intended for use in the electromagnetic environment
specified below. The customer or the user of the eVu TPS should assure
that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic
discharge
(ESD)
IEC 61000-
4-2
±8kV
contact
±15 kV air
±8kV
contact
±15 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least
30 %.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

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Warnings and Precautions
Read all warnings, precautions, and instructions
carefully before use. Follow all operating and
maintenance guidelines as described in this
document.
WARNINGS:
Intended Use
•There are no user serviceable parts.
Do not attempt to service or modify
the equipment. If the equipment
appears damaged, do not use; contact
Technical Support at Thought
Technology Ltd. or your local
authorized distributor for
replacement.
•Functionality is disabled during
charging. To ensure safety, do not
charge the device while wearing.
•Do not immerse in water.
•Do not connect to a patient
undergoing MRI, electro-surgery or
defibrillation.

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•Do not use in the presence of a
flammable anesthetic mixture with air
or with Oxygen or Nitrous Oxide.
•Device might not meet its
performance specifications if
transported, stored or used outside
the specified temperature and
humidity ranges.
•Skin temperature readings are
sensitive to air movement and incident
radiation.
•Use of any equipment in a biofeedback
context should be immediately
terminated upon any sign of distress
or discomfort.
•This device is not intended for
diagnosis and it is not a substitute for
proper medical advice and diagnostic
testing. If you have any health
concerns, consult your physician.
PRECAUTIONS
•The eVu TPS may be susceptible to
electrostatic discharges (ESD) and
radiated radio frequency (RF) fields.

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Electrostatic discharge is common in
conditions of low humidity. Always
discharge yourself by touching a
grounded bare metal surface before
touching the unit. Do not operate
active sensors within 10 feet (3m) of a
powerful radio interference producing
sources such as arc welders, radio
thermal treatment equipment, x-ray
machines or any other equipment that
produces electrical sparks.
•
Bluetooth operation may be
interrupted by presence of interfering
devices in the 2.4 GHz IsM band.
•To avoid the risk of electrical shock,
inspect the AC power adapter / Charger
and AC power cord on a regular basis.
Ensure they are not damaged. If you
detect damage or excessive heating,
remove from the wall outlet immediately
and contact Technical Support at
Thought Technology Ltd. or your local
authorized distributor for replacement.

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•Never position the AC power adapter /
Charger near combustible materials.
Ensure that the Charger remains
accessible at all times and may be
easily disconnected from the wall
outlet.
•Do not expose to extreme weather
conditions.
•To diminish the risk of spreading
communicable diseases, always use
good hygiene practices with electrode
surfaces. In all cases, refer to your
facility's infection control procedure.
WARNINGS:
Battery
•To ensure safety, use only the charging
adapter provided with the device.
•Do not leave a battery on prolonged
charge when not in use.
•Discard the device with built-in battery
following your local waste
management legislation and
guidelines. The battery cannot be
replaced.

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Maintenance and Care
•There are no user serviceable parts.
•
Wipe sensor pads with a clean cloth after each
use. Do not clean with alcohol or abrasive
detergents. Do not immerse, soak or expose
the sensor to disinfectants for periods of time
that exceed manufacturer’s specifications. Do
not sterilize.
•
If the device is not used for a long time, ensure
the device is charged at minimum every 2-3
months.
•The battery can maintain the performance
characteristics for a minimum of 300 charge
cycles.
•After extended periods of storage, it may be
necessary to charge and discharge the device
several times to obtain maximum
performance.
•
To ensure safety, use only the charging
adapter provided with the device.
•Do not leave a battery on prolonged
charge when not in use.

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•Discard the device with built-in battery
following your local waste
management legislation and
guidelines. The battery cannot be
replaced.

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Instructions for Use
Wearing the device
Step 1:
Attach the TPS fabric strap to the TPS sensor by
slipping the two loops at the one end of the strap
onto the two outer hooks of the TPS sensor.
Step 2:
Place the TPS sensor on your
finger so that the sensor label
faces up and the ON button
points toward your hand.
It does not matter upon which
finger the sensor is placed.