Articulate Instruments PTU User manual

PTU
™
0473
USERS MANUAL
Revision 1.10
ELECTROPALATOGRAPH
PORTABLE TRAINING UNIT
Address:
Articulate Instruments Limited
Queen Margaret Campus, Queen Margaret University Drive
Musselburgh EH21 6UU
UK
Phone: [phone]
Fax: [phone]
Email:[e-mail]
Information in this document is subject to change without notice and does not represent a
commitment on the part of Articulate Instruments Ltd. No part of this manual may be
reproduced or transmitted in any form or by any means, electronic or mechanical, including
photocopying and recording, for any purpose without the written permission of Articulate
Instruments Ltd.

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 1

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 2
Contents
Definitions........................................................................................................ 3
Warranty.......................................................................................................... 3
CE Marks on electrical devices........................................................................ 3
General EMC (Electromagnetic Compatibility) Guidelines .............................. 3
Electromagnetic Interference..................................................................... 3
Declaration of Conformity ............................................................................. 4
Safety Precautions .......................................................................................... 5
Some Do’s and Don’ts on the Safe Use of the WinEPG™ System .............. 5
Getting Started ................................................................................................ 6
Inspection ..................................................................................................... 6
System Features .......................................................................................... 6
PTU™ System Description........................................................................... 6
EPG palate ................................................................................................ 7
Multiplexer ................................................................................................. 7
PTU ........................................................................................................... 8
System Setup ............................................................................................... 9
Using the Freeze button ............................................................................. 10
Replacing the Batteries .............................................................................. 11
Adjusting the Palate Threshold................................................................... 12
Technical Details ........................................................................................... 12
Specifications ............................................................................................. 12
Multiplexer ............................................................................................... 13
General Environmental............................................................................ 13
Meaning of symbols on rear panels......................................................... 13
Electrical Safety.......................................................................................... 13
On-site Calibration Check........................................................................... 14
WinEPG Maintenance ................................................................................ 14
EPG Palate Assembly ................................................................................... 15
Palate Layout.............................................................................................. 15
Preparation for use of EPG palate.............................................................. 16
Care of the EPG Palate .............................................................................. 16
Wiring Connections for the EPG Palate...................................................... 17
Guidelines for preparing plaster models ..................................................... 17
Manufacturers of EPG palates.................................................................... 18
Troubleshooting............................................................................................. 19
FAQ ............................................................................................................ 19
Contact ....................................................................................................... 20

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 3
Definitions
EPG Electropalatograph
SPI Serial Port Interface unit
D.C. Direct current
LED Light Emitting Diode
PTU Portable Training Unit
Warranty
Articulate Instruments Ltd warrants the Electropalatograph against defects in
materials and workmanship for a period of one year from receipt by the user.
During that warranty period, Articulate Instruments will either, at its option,
repair or replace products, which prove to be defective. Articulate Instruments
can accept no responsibility if the Electropalatograph is used other than in
accordance with the instructions supplied. This warranty applies to the initial
purchaser only and is not transferable. Full Terms and Conditions are
contained in the Warranty Terms and Conditions enclosed with the system.
CE Marks on electrical devices
The European Union has introduced directives requiring CE marks on
devices.
Non medical devices marked with indicate compliance with relevant
directives. Electropalatography systems (WinEPG/PTU) sold as medical
devices comply with EEC Council Directive 93/42/EEC of 14 June 1993
concerning Medical Devices. 0473 applies to class IIa.
NOTE: For therapeutic use palates must be manufactured by Incidental as the
only approved supplier.
General EMC (Electromagnetic Compatibility) Guidelines
Electromagnetic Interference
Electromagnetic interference (EMI) is any signal or emission, radiated in free
space or conducted along power or signal leads, that endangers the
functioning of a radio navigation or other safety service or seriously degrades,
obstructs, or repeatedly interrupts a licensed radio communications service.
The PTU™ system is designed to comply with applicable regulations
regarding EMI. In particular it complies with standards for medical electrical
equipment and information technology equipment used in medical electrical
application.

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 4
Declaration of Conformity
Marking
Manufacturer:
Articulate Instruments Ltd.
Queen Margaret Campus
Queen Margaret University Drive
Musselburgh EH21 6UU UK
[phone]
[phone] (Facsimile)
Product Designation: Electropalatograph (Models WinEPG and PTU)
The above mentioned products meet the essential requirements of:
1. The Medical Device Directive 93/42/EEC, Statutory Instrument 2002 No.
618, classified as a Class IIa medical device (Annex IX rule 9).
2. Canadian Medical Devices Regulations (PC 1998-783, 7 May 1998),
classified Class II (CMDR rules 9,10)
Standards to which Conformity is declared:
ISO 9001:2008 Quality management systems: except service & installation
ISO 13485:2003 Medical Devices: Quality Management systems: except service &
installation
ISO 14971:2009 Application of risk management to medical devices
IEC 980:2008 Symbols for use in the labelling of medical devices
IEC 60601-1:1990 +A1:1993, A11:1993, A12:1993, A2:1995, A13:1996 Medical
electrical equipment – general requirements for safety
IEC 60601-1-1:2001 Safety requirements for medical electrical systems
IEC 60601-1-2:2007 Electromagnetic compatibility – requirements and tests
IEC 60601-1-4:1996 Safety of programmable electrical medical systems
MDR (PC 1998-783, 7 May 1998) Canadian Medical Devices Regulations
Annex VI & VII MDD 93/42EEC Medical Device Directive
Notified Body:
AMTAC Certification Service Limited
www.intertek-acsl.com
Notified Body Number: 0473
Testing Laboratory:
SGS United Kingdom Ltd
www.uk.sgs.com
UKAS No 1116
Certificate No.: 637CE
I, the undersigned, hereby declare that the equipment specified by this
declaration conforms to the listed directives and standards
Signature: Date: 20 October 2009
Name: Alan Wrench
Position: Managing Director

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 5
Safety Precautions
WARNING: To Prevent Fire or Shock Hazard, Do not expose this system
(except the palate) to rain or moisture.
CAUTION
• When you are not using the PTU™ system for a long period of time, it is
recommended that you remove the batteries from the PTU™ unit.
• Refer internal servicing to qualified service personnel.
ATTENTION: Under normal circumstances, the duration of EPG therapy
should not be longer than sixty (60) minutes.
WARNING
• Potential EPG users with a heart PACEMAKER should NOT USE EPG
until they have discussed the risks with their GP and the manufacturer of
the pacemaker.
Some Do’s and Don’ts on the Safe Use of the WinEPG™ System
This equipment has been designed and manufactured to meet international
safety standards but, like any electrical equipment, care must be taken if you
are to obtain the best results and safety is assured.
DO read the operating instructions before you attempt to use the equipment
DO ensure that all electrical connections (including the mains plug, leads and
interconnections between pieces of equipment ) are properly made and in
accordance with manufacturer’s instructions.
DO consult the manufacturer if you are ever in doubt about the installation,
operation or safety of your system.
DON’T continue to operate the equipment if you are in doubt about it working
normally, or if it is damaged in any way.
NEVER walk around with the multiplexer around your neck
ALWAYS have a responsible adult (preferably a clinician) supervising
children or adults with incapacity that are using EPG.
ALWAYS visually inspect the EPG palate for any signs of damage prior to
every use.

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 6
Getting Started
Inspection
Upon receipt of your WinEPG system (or upgrade system), it should be
examined immediately for any evidence of damage. Damaged shipments
should be reported promptly to the carrier, who is normally liable for such
damage.
All documentation, airway bills and packing materials should be retained in
order to establish claims. After notifying the carrier of shipping damage, please
also advise Articulate Instruments so that we may assist in damage claims and
supply replacement equipment if necessary.
System Features
− Safety. No direct connection between client and power
source. All connections are capacitance coupled.
Maximum signal current is 50 micro amperes
− Low running costs. Designed to have low power
consumption. Around 100 hours continuous use from one
set of batteries. Automatic shutdown after 20minutes with
no use, to conserve batteries if unit accidentally left on.
− Compatibility. Uses the same multiplexer and palate as
EPG3
− Portability. The system comes in its own carry case,
making it easy to store and transport between clinic and
home.
PTU™ System Description
The Portable Training Unit (PTU) system includes the following supplied
components:
− Multiplexer with chrome handgrip
− PTU™ display unit
− Carry case
− Threshold adjustment screwdriver
− Optional Freeze button
To operate the system the following additional items are required:
− An EPG palate, custom made for each client

Manual for PTU System. Document No. PTUManual_1.10
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Figure 1 PTU™ system hardware
EPG palate
The EPG palate (1F) comprises an acrylic palate fitted with 62 silver contacts
wired to a multiplexer input connector. EPG palates must be manufactured to
fit each individual client. See Appendix for EPG palate manufacturer address.
Before use the EPG palate should be inspected for any defects that might put
the patient at risk (e.g. breaks, cracks etc).
Multiplexer
The EPG palate plugs into the connector slot on the multiplexer (Figure 2E),
which is suspended from a cord around the client’s neck.
E.Multiplexer
F. EPG palate
D
. Chrome
handgrip
A
.Carry case
C
. Portable
Training Unit
B
. Palate
case
G
. Freeze
button

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 8
WARNING The lanyard should never be tied at the free end, as this
would pose a risk of the wearer being strangled by the lanyard if the
unit catches on something.
Figure 2 Correct use of the lanyard (neck cord)
The lanyard located in the top of the multiplexer should be slipped through the
bracket which is also mounted on the top of the mutiplexer. The cord will grip
without the need to tie a knot and may be adjusted by pulling it through the
bracket until the unit rests at a comfortable height. Ideally the multiplexer
should be high on the chest so that there is no strain on the palate cables.
The client should hold the chrome handgrip, which plugs into the side of the
multiplexer box to complete the contact circuit.
The palate should always be plugged into the multiplexer BEFORE it is placed
in the client’s mouth and DO NOT REMOVE PALATE CONNECTOR WHILST
THE CLIENT IS IN CONTACT WITH THE APPARATUS. This is to prevent
the possibility that the connector end could come into contact with a surface
or piece of equipment that is live or earthed. Likewise the handgrip should
always be plugged into the multiplexer before being handed to the client.
PTU
The Portable Training Unit (PTU™)(Figure 3) controls and scans the input
from the multiplexer, then decodes and displays the EPG contact pattern at
around 300 times a second. The PTU™ incorporates an on/off switch (2C), a
battery indicator (2B) and a threshold adjustment control (2D). The PTU™ is
powered by 6 AA batteries and is designed to last for many hours before
needing to change the batteries. There is an automatic shutdown which
prevents battery drain if the unit is left unused for more than 20 minutes.

Manual for PTU System. Document No. PTUManual_1.10
Copyright 2001-2010 Articulate Instruments Ltd 9
Figure 3 Front panel of PTU.
System Setup
The Portable Training Unit is simple to use; with only one user control: An
on/off switch.
1. Switch on the PTU™ to check the battery level. If the needle on the
battery meter is in the red region then the batteries need to be
replaced. NB. If the PTU™ has been left on accidentally
then the PTU™ should be switched off then on again to read the meter.
It may be necessary to wait a few seconds between switching the unit
off and on again to reset the automatic shutdown.
2. Switch off the PTU™ and replace batteries if necessary (see section on
Replacing the Batteries).
3. Plug the multiplexer cable into the socket marked “INPUT” on the front
of the PTU.
4. Plug the chrome handgrip (1D) into the multiplexer.
5. Plug the EPG palate worn by the client into the multiplexer as shown in
Figure 4.
The PTU™ is now ready to be used with a client.
6. Get the client to fit the EPG palate into their mouth. This should ideally
be done 15 minutes or more before recording to allow the client to
become accustomed to the palate.
7. Hang the multiplexer (1E) around the client’s neck, pulling the cord
through the hole in the bracket to ensure the multiplexer rests at a
comfortable height and so that there is no strain on the EPG palate
when it is in the subject’s mouth.
8. Switch on the PTU.
9. Get the client to hold the chrome handgrip.
C
. On/off
D
. Threshold
Adjustment
B
. Battery indicator
A
. Input
E
. Freeze button
socket