Oxford Medelec Synergy Mobile Instruction manual

Synergy Mobile
Medelec®Multimedia EMG / EP
Workshop Manual
034W003 Issue A
OXFR
Issue A May 1998

Oxford Instruments
Medical Systems Division
NP Customer Support Group
Manor Way,
Old Woking,
Surrey,GU22 9JU, UK
Tel: +44 (0)1483 770331
Direct Tel: +44 (0)1483 246 228
“ “ “ 229
“ “ “ 230
“ “ “ 266
“ “ “ 267
Fax:+44 (0)1483 727193
www.oxford-instruments.com I
©OXFORD INSTRUMENTS plc 1998
COPYRIGHT : All rights reserved. No part of this Workshop Manual may be reproduced, stored
in a retrieval system or transmitted in any form or by any means, electronic, mechanical,
photocopying, recording or otherwise, without the prior permission of Oxford Instruments,
Medical Systems Division.
Trademarks
The following trademarks are referred to throughout this Workshop Manual. These are
trademarks or registered trademarks of the companies shown below.
Melelec and TECA are registered trademarks of Oxford Instruments, Medical Systems
Division in the UK and other countries.
Microsoft and Windows 95 are registered trademarks of the Microsoft Corporation.
Pentium is a trademark of the Intel Corporation.
EMG LivePlay™ and LongTrace™ are trademarks of Oxford Instruments, Medical
Systems Division.
Screen Captures
Various screen captures (portions of the display) are shown throughout this Workshop
Manual. These are either copyright of the Microsoft Corporation or Oxford Instruments
Medical Systems Division.
ISSUE A May 1998

Customer support is also available from your local Oxford Subsidiaries at the following
Addresses: Or your local Oxford distributor.
FRANCE ITALY
Oxford Instruments SA Oxford Instruments Spa
Medical Systems Division Medical Systems Division
Parc Club – Orsay Université Via Leone Tolstoi 86
27 rue Jean Rostand 20098 San Giuliano Milanese
91893 Orsay Cedex Milano
Tel: +33 (1)69 41 89 90 Tel: +39 (0)2 982 531
Fax: +33 (1)69 41 86 80 Fax:+39 (0)2 982 41407
GERMANY Spain
Oxford Instruments GmbH Oxford Instruments SA
Medical Systems Division Medical Systems Division
Kreuzberger Ring 38 Av.Mata Pinõnera 2
D-65205 Wiesbaden 28700 San Sebastian de los Reyes
Postfach 4509 Madrid
D-62035 Wiesbaden Tel: +34 (1)653 8198
Tel: +49 (0)611 764-0 Fax: +34 (1)654 6794
Fax: +49 (0)611 764100
Netherlands Belgium
Oxford Instruments NV Oxford Instruments NV
Medical Systems Division Medical Systems Division
Avelingen West 1 Molenberglei 21
4202 MS, Gorinchem 2627 Schelle
Tel: +31 (1) 836 92111 Antwerp
Fax: +31 (1) 836 92119 Tel: +32 (3) 880 8280
Fax: +32 (3) 844 7842
IMPORTANT
The information contained in this Workshop Manual is liable to change without notice.
This copy of the Workshop Manual is at Issue A. The chapters contained within it are at
the following issues :–
Chapter Title Issue
Table of Contents A
Introduction A
Technical Specification A
Installation and Operation A
Technical Overview A
Patient Safety Checks A
System Functional Checks A
Firmware History A
Fault Finding A
Servicing A
Customer Options and Spares A
Index A
Issue A May 1998

Table of Contents
INTRODUCTION ........................................1
TECHNICAL SPECIFICATION .................................2
Amplifiers········································2.1
A to D Conversion····································2.2
Data Storage ······································2.3
Electrical Stimulator ···································2.4
Auditory Stimulator ···································2.5
Visual Stimulator ····································2.6
PC Tower ········································2.7
DSP Card ·······································2.8
Graphics Card (Option) ·································2.9
Display (Options)····································2.10
Network Card (Option)·································2.11
Isolation transformer / Power Supply ··························2.12
Software ········································2.13
Size and Weight ····································2.14
Operating Conditions ··································2.15
Safety Standards ····································2.16
Quality Standards····································2.17
INSTALLATION AND OPERATION ..............................3
Operating Restrictions: Cautions and Warnings ······················3.1
Disclaimer ·······································3.2
Signal Cables ······································3.3
Installation ·······································3.4
Routine Maintenance ··································3.5
Controls·········································3.6
PC Tower rear Connector Panel ·····························3.7
Peripheral Connectors ··································3.8
TECHNICAL OVERVIEW....................................4
The PC Motherboard···································4.1
The DSP Sub-System ··································4.2
The Control Panel & Electrical Stimulators. ·······················4.3
The Evoked Potential Stimulators·····························4.4
The Two Channel Headbox ·······························4.5
The 5 Channel Headbox ·································4.6
The 10 Channel Headbox ································4.7
Issue A May 1998
Synergy Mobile Workshop Manual i

PATIENT SAFETY CHECKS ..................................5
Equipment Required ···································5.1
Initial Checks ······································5.2
Signal Input ·······································5.3
EMG Stimulus Output ··································5.4
Earth Leakage Current Tests ·······························5.5
Patient Leakage Current Tests ······························5.6
Patient Auxiliary Current (Headbox) ···························5.7
Patient Auxiliary Current (Stim A) ····························5.8
Patient Auxiliary Current (Stim B) ····························5.9
EMG Safety Checks ··································5.10
Audiometric Headphone Cut-Off Checks ························5.11
SYSTEM FUNCTIONAL CHECKS ...............................6
Equipment Required ···································6.1
Initial Checks ······································6.2
System Checks ·····································6.3
CD-ROM Drive Checks ·································6.4
2 Channel Headbox Checks ·······························6.5
5 and 10 Channel Headbox Checks ····························6.6
Trigger / Gain / Sweep Control Checks ··························6.7
Amp Cal Mode ·····································6.8
Electrode Impedance Mode································6.9
Temperature Probe Checks ·······························6.10
Control Panel Internal EMG Stimulator Checks ·····················6.11
EMG Stimulator Probe Checks ·····························6.12
External Speaker Checks ································6.13
Footswitch Checks ···································6.14
Parallel & Serial Port Checks ······························6.15
Networking Checks···································6.16
EP Stim Checks ····································6.17
FIRMWARE HISTORY .....................................7
Introduction ·······································7.1
Firmware ········································7.2
FAULT FINDING ........................................8
SERVICING ...........................................9
Removing Parts From Inside The Tower ·························9.1
Removing the Disk Drives ·······························9.2
Upgrading components on the motherboard ························9.3
Removing The PC Speaker································9.4
ii Synergy Mobile Workshop Manual
Issue A May 1998

Removing The Isolation Transformer and Power Supply ·················9.5
CUSTOMER OPTIONS AND SPARES .............................10
Hardware, Software, Spares and Options ························10.1
Recommended Spares··································10.2
Issue A May 1998
Synergy Mobile Workshop Manual iii

INTRODUCTION
The Synergy Mobile EMG system is mounted on
a trolley and is based around a Pentium PC tower,
running under Windows 95. The system
incorporates the latest advances in technology for
transportable neurodiagnostic systems.
Synergy Mobile can have its own neurodiagnostic
applications software running at the same time as
other applications, as Windows 95 allows true
multitasking. However, performance may be
affected according to the system configuration e.g.
the amount of memory installed, processor speed
etc. so it is essential that the system is configured
according to the users requirements.
The equipment is operated through a dedicated
control panel or through the GUI (Graphical User
Interface) using a pointing device (e.g. mouse) to
access various screen “buttons”.
The Synergy Mobile uses an external high
resolution colour monitor.
The system can have two, five or ten amplifier
channels for monitoring patient signals. An
external loudspeaker is provided to listen to the
patient signals. Headphones can be connected if
required to monitor these signals.
EMG Stimuli to the patient can be delivered via a
maximum of two electrical stimulators. These can
be a single internal stimulator, which is contained
in the control unit and an external hand held
stimulator probe, or alternatively two probes. Each
hand held stimulator probe has its own controls
for setting the stimulus intensity, duration, polarity
and controlling acquisition.
An optional EP Stimulator providing audiological
stimuli to headphones and visual stimuli to an
external monitor can also be installed. Outputs are
also provided for supplying external visual
stimulators such as LED goggles or a flash head.
Hard copies of patient data can be recorded on an
external printer. The type of printer used is only
limited by the range available to Windows 95.
Patient data can be stored on floppy disks via the
internal floppy drive or on the internal hard disk.
An internal CD-ROM drive is fitted as standard to
allow other Windows 95 based software packages
to be installed.
Communication with other systems can be made
via an optional network card or modem to allow
transfer of patient data between systems.
Each system comes complete with the following
items.
¨
PC tower with full PC keyboard
¨
Isolation transformer/ Power supply
¨
Control unit includes internal EMG stimulator
¨
Connection box
¨
2, 5 or 10 channel Headbox
¨
Single or triple footswitch (optional)
¨
Pointing device (mouse)
A variety of applications software packages are
available for installation in the Synergy Mobile
which will enable the user to perform their
required clinical tests (see chapter 10). These can
either be installed with the system when purchased
or bought as an “add-on” at a later date.
Throughout this manual, the “pointing device”
will be assumed to be a mouse. If using another
device, read “other device” for “mouse”.
When instructed to “click” on a button, this
means move the pointer to the “button” icon
referred to on the screen, and then press the
left hand mouse button.
A knowledge of Windows 95 is essential in order
to be able to use the Synergy Mobile system. This
information can be obtained from your Windows
95 documentation, and from the many help
screens available from within Windows 95. To
call up the Windows 95 help screen menu once
INTRODUCTION ISSUE A March 1998
Synergy Mobile Workshop Manual Chapter 1 Page 1
INTRODUCTION
The Synergy Mobile EMG system is mounted on
a trolley and is based around a Pentium PC tower,
running under Windows 95. The system
incorporates the latest advances in technology for
transportable neurodiagnostic systems.
Synergy Mobile can have its own neurodiagnostic
applications software running at the same time as
other applications, as Windows 95 allows true
multitasking. However, performance may be
affected according to the system configuration e.g.
the amount of memory installed, processor speed
etc. so it is essential that the system is configured
according to the users requirements.
The equipment is operated through a dedicated
control panel or through the GUI (Graphical User
Interface) using a pointing device (e.g. mouse) to
access various screen “buttons”.
The Synergy Mobile uses an external high
resolution colour monitor.
The system can have two, five or ten amplifier
channels for monitoring patient signals. An
external loudspeaker is provided to listen to the
patient signals. Headphones can be connected if
required to monitor these signals.
EMG Stimuli to the patient can be delivered via a
maximum of two electrical stimulators. These can
be a single internal stimulator, which is contained
in the control unit and an external hand held
stimulator probe, or alternatively two probes. Each
hand held stimulator probe has its own controls
for setting the stimulus intensity, duration, polarity
and controlling acquisition.
An optional EP Stimulator providing audiological
stimuli to headphones and visual stimuli to an
external monitor can also be installed. Outputs are
also provided for supplying external visual
stimulators such as LED goggles or a flash head.
Hard copies of patient data can be recorded on an
external printer. The type of printer used is only
limited by the range available to Windows 95.
Patient data can be stored on floppy disks via the
internal floppy drive or on the internal hard disk.
An internal CD-ROM drive is fitted as standard to
allow other Windows 95 based software packages
to be installed.
Communication with other systems can be made
via an optional network card or modem to allow
transfer of patient data between systems.
Each system comes complete with the following
items.
¨
PC tower with full PC keyboard
¨
Isolation transformer/ Power supply
¨
Control unit includes internal EMG stimulator
¨
Connection box
¨
2, 5 or 10 channel Headbox
¨
Single or triple footswitch (optional)
¨
Pointing device (mouse)
A variety of applications software packages are
available for installation in the Synergy Mobile
which will enable the user to perform their
required clinical tests (see chapter 10). These can
either be installed with the system when purchased
or bought as an “add-on” at a later date.
Throughout this manual, the “pointing device”
will be assumed to be a mouse. If using another
device, read “other device” for “mouse”.
When instructed to “click” on a button, this
means move the pointer to the “button” icon
referred to on the screen, and then press the
left hand mouse button.
A knowledge of Windows 95 is essential in order
to be able to use the Synergy Mobile system. This
information can be obtained from your Windows
95 documentation, and from the many help
screens available from within Windows 95. To
call up the Windows 95 help screen menu once

the operating system has loaded, move the mouse
pointer to the “task bar”. This is normally hidden
but will appear when the mouse is moved to the
very edge of the screen (the default setting is the
bottom edge). If the task bar does not appear, press
the “Ctrl” and “Esc” buttons on the keyboard
together to show the start menu which will also
make the task bar appear. When the “task bar” is
displayed, click on the “Start” button on the task
bar, and when a menu list appears, click on the
“Help” button (see Figure 1.1).
The “Help Topics” window will then be displayed,
and it is then a simple matter of following the
on-screen instructions. If you want to search for a
particular word in the help screens, click on the
“Find” button. Follow the instructions on the
screen to create a word database and then search
for the required word.
Help screens are also available within individual
applications software packages. The help menu is
normally accessible by pressing the “F1” function
key on the keyboard, or by calling it up from the
menu toolbar using the mouse.
Issue A May 1998 INTRODUCTION
Chapter 1 Page 2 Synergy Mobile Workshop Manual
Figure 1-1 Selecting “Help”

TECHNICAL SPECIFICATION
2.1 Amplifiers
2.1.1 Input Channels
There are two, five and ten channel variants of the
headbox.
2.1.2 Headbox Connections
Two Channel
Two red, two black 1.5mm touchproof sockets for
+ve and –ve inputs. One green 1.5mm touchproof
socket for neutral.
Two 5 pin DIN sockets with +ve, –ve, neutral and
driven screen.
One 3.5mm jack socket for temperature probe
input
Five Channel
18 grey 1.5mm touchproof sockets (12 cephalic in
10-20 format, 6 non-cephalic). Two green 1.5mm
touchproof sockets for neutral.
Two 5 pin DIN sockets with +ve, –ve, neutral and
driven screen.
Software montaging defines input switching.
One 3.5mm jack socket for temperature probe
input
On 25 way D-type socket for remote jackbox
connection
Ten Channel
18 grey 1.5mm touchproof sockets (12 cephalic in
10-20 format, 6 non-cephalic). Two green 1.5mm
touchproof sockets for neutral.
Two 5 pin DIN sockets with +ve, –ve, neutral and
driven screen.
Software montaging defines input switching.
One 3.5mm jack socket for temperature probe
input
On 25 way D-type socket for remote jackbox
connection
2.1.3 Headbox Cable Length
2.5metres standard detachable at mainframe and
headbox.
2.1.4 Performance
Input Impedance : 1000MΩ<30pF
CMRR : >110dB
Noise : <0.7µV r.m.s. (0.1 – 10kHz
bandwidth) with inputs
connected to neutral through
5kΩ
Differential
offset range : >±2V
Common mode
offset range : >±5V
2.1.5 Impedance Test
Two Channel
LED display in headbox, with an indication at
<2, <4, <8, <16, <32, and >32kΩ
Accuracy : ±0.5kΩbetween 2kΩand 5kΩ
Test Current : <10µA a.c.
Electrode selection on headbox using push-buttons
located adjacent to the touchproof input sockets.
Five and Ten Channel
Pass/Fail indication on headbox (by LED) and also
on mainframe. Level selectable on headbox and at
mainframe.
Accuracy : ±0.5kΩbetween 2kΩand 5kΩ
2.1.6 Calibration Signal
Squarewave signal generated within the headbox at
5µV, 50µV, 500µV, and 5mV pk-pk amplitude
±10%
2.1.7 Sensitivity
Hardware gains of x10, x50, x500, and x2000
accurate to ±5% within the headbox.
Sensitivities of 2µV to 10mV in 2, 5, 10 steps
available via software control using DSP.
2.1.8 Filters
Hardware High Pass filters at -6dB per octave with
-3dB points at 0.01Hz, 0.1Hz, 0.3Hz, 1Hz, 3Hz,
10Hz, and 20Hz, accurate to ±10%.
A D.C. setting is also available on the 5 channel
headbox, with input offset removal for up to
±500mV of offset.
All other filters available via software control
using DSP as follows :–
High Pass Filters
-6dB per octave with -3dB points at 30, 50, 100,
200, 500Hz, 1 and 2kHz, and D.C.
Low Pass Filters
-12dB per octave with -6dB points at 50, 100,
200Hz, 1, 1.5, 2, 3, 5, 10, and 20kHz.
Notch Filters
Frequency : 50 or 60Hz, software
switchable in and out
TECHNICAL SPECIFICATION Issue A May 1998
Synergy Mobile Workshop Manual Chapter 2 Page 1

2.1.9 Temperature Probe
Temperature Range 15°Cto40°C with 0.1°C
resolution, 0.2°C accuracy for use with YSI series
400 or 4400 probes with resistance of 2253Ωat
25°C. Reusable and Disposable types available
(see chapter 10 )
Note: Disposable types cannot be connected
directly an extention/adaptor cable is required.
2.2 A to D Conversion
Resolution
16 bits at all sampling rates.
2 Channel Headbox Sampling Rate
2 channels : 20µs/sample 50kHz
5 Channel Headbox Sampling Rates
1–3 channels : 20µs/sample 50kHz
4 and 5 channels 50µs/sample 20kHz
10 Channel Headbox Sampling Rates
1–3 channels : 20µs/sample 50kHz
4-10 channels : 50µs/sample 20kHz
2.3 Data Storage
Hard Disk
Interface : Enhanced IDE
Disk Size : 2.5GByte formatted
For storing the Windows 95 operating system
software and the Synergy Mobile applications
software and EMG test routines. Also used for
storing trace data, patient data etc.
Floppy Diskette
Physical size : 3½" disk drive
Data capacity : 2MByte unformatted
1.44MByte unformatted
For installing the Windows 95 operating system
software (floppy version), the Synergy Mobile
applications software, and any upgrades.
CD-ROM
Interface : Enhanced IDE
Speed : 24 speed drive
For installing the Windows 95 operating system
software (CD-ROM version) and applications
software. The CD-ROM cannot be written to.
2.4 Electrical Stimulator
One or two stimulators.
Constant voltage/constant current with low or high
range.
Voltage Output : High Range-0to300V
Low Range-0to75V
Current Output : High Range-0to100mA
Low Range-0to25mA
Repetition Rates : Fine adjustment available up
to 200pps. (Up to 500pps in
a train for pain studies).
Stim Duration : 0.05, 0.1, 0.2, 0.5, 1.0ms
Ranges in between those shown are software
selectable.
At a repetition rate of 200pps and an intensity of
300V/100mA, the maximum stimulus duration is
0.2ms. At a repetition rate of 100pps and an
intensity of 300V/100mA, the maximum stimulus
duration is 0.5ms.
Delay : ±0to 9 screen divisions
Output Impedance : <100Ωfor voltage stimulus
>100kΩfor current stimulus
Stimulus modes : Single, refractory, collision,
double, train, bi-phasic
Stim fail is reported for electrode impedance too
high in current mode or too low in voltage mode.
2.5 Auditory Stimulator
The auditory stimulus can be administered via
various transducers e.g. audiometric headphones,
bone conductor and intra-auricular headset which
should be isolated to type BF classification.
Modes : Clicks, pips and tone bursts
Stimulus
presentation : Right, left or binaural.
Polarity : Positive, negative or
alternating.
Masking : Contralateral, ipsilateral, and
bilateral white noise and
narrow band masking; +10 to
–40dB and OFF referred to
stimulus intensity.
Click Intensity : 0 to 110dBHL (122dBSPL
max. output) in 5dB
increments
Pip and Tone : 0 to 120 dBnHL
Intensity (132dBSPL max. Output)
in 5dB increments
Envelopes : Linear, Hanning, Gaussian,
Blackman
Compensation : SPL, nHL, and subjective
hearing compensation
Chapter 2 Page 2 Synergy Mobile Workshop Manual
Draft March 1998 TECHNICAL SPECIFICATION

Stimulus Duration
Click : 0.05 - 1.0ms
Pip Rise/Fall : 1-255 cycles in 1 cycle steps
Pip Plateau : 1-999 cycles in 1 cycle steps
Tone Rise/Fall : 1-255ms in 1ms steps
Tone Plateau : 1-999ms in 1ms steps
Pip and Tone : 125Hz, 250Hz, 500Hz, 750Hz,
frequencies 1kHz, 1.5kHz, 2kHz, 3kHz,
4kHz, 6kHz, and 8kHz
Headphones : Telephonics TDH-49 type BF
The EP Stimulator board is able to save calibration
settings for up to four different transducers.
A microphone input is available to talk to the
patient through the headphones in auditory tests.
2.6 Visual Stimulator
The visual stimulator operates in conjunction with
one of the following types of external monitor :–
¨
VGA
¨
SVGA
¨
50Hz/625 line TV standard
¨
60Hz/525 line TV standard
¨
100Hz
A variety of test presentations are provided as
follows.
Pattern : Checkerboard, horizontal or
vertical bars, horizontal or
vertical sinusoidal gratings
Stimulus Presentation
: Reversal or Onset/Offset.
Fields : Full field, half field, quarter
field, peripheral and foveal
Pattern Size : 8, 16, 32, 64 & 128 pattern
elements
Fixation : Electronic Fixation Point with
range of sizes
Contrast : 20, 40, 60, 100%
Frame rate : 50Hz or 60Hz switchable with
software
The visual stimulator can also be connected
directly to a Flash Stimulator, and via and to LED
Goggles, EOG Stimulator, or Ganzfeld Stimulator.
2.7 PC Tower
Processor : 200 or 233MMX Pentium
Level 2 cache : 512kbytes
Memory : 32MByte EDO RAM
expandable to 192MByte
Disk Controllers : Floppy Disk Drive
Primary and secondary IDE
Ports : 2 Enhanced serial
1 Enhanced parallel
PC Graphics : Trio S3 64 bit video controller
1280 x 1024
2.8 DSP Card
Loughborough Sound Images (LSI) PCI/C44-nM
DSP designed specifically for Oxford Instruments.
(Where n= the number of DSP’s fitted to the
board)
Card type : Standard length PCI
Interface : Full PCI master/slave
Processor type : TMS320C44 (60MHz). Up to
three can be installed,
dependent on system
configuration
Memory : 128k x 32 local SRAM/proc.
128k x 32 global SRAM/proc.
128k x 32 shared SRAM
2.9 Graphics Card (Option)
Card type : Matrox Millennium
Resolution : Up 1600 x 1200
Colours : 64K
Memory : 4MByte
2.10 Display (Options)
17" or 21" Multi-sync colour SVGA monitor.
NOTE: Only the 17" monitor is suitable for
mounting on the trolley arm. The 21" monitor is
too heavy to be mounted on the arm.
2.11 Network Card (Option)
Network card (3 COM type) currently supplied.
TECHNICAL SPECIFICATION Issue A May 1998
Synergy Mobile Workshop Manual Chapter 2 Page 3

2.12 Isolation transformer / Power
Supply
Operates from mains inputs of 100V – 120V at
50-60Hz, or 200V – 240V at 50-60Hz. 1250VA
The unit has a switch to change the operating
voltage.
AThe power supply must be connected to a
mains supply complying with one of the two
ranges specified above, or serious damage
to the power supply may result.
ABoth the mains in selector switch and
isolated mains out selector switch must be
set to the same range.
The isolation transformer provides eight isolated
mains outlets at 100V – 120V, or 200V – 240V
50-60Hz. Maximum load on these outlets is not to
exceed 1150VA. The unit has a switch to change
the voltage of these outlets.
The isolation transformer also provides isolated
mains for the following DC supplies:-
+24V 2.5A
+12V 1A
-12V 1A
-24V 1A
2.13 Software
2.13.1 Standard Software
The following software is installed as standard on
all systems :–
¨
Full patient database with user-configurable
fields (ODBC compliant)
¨
Protocol Wizard for user defined test settings
¨
On-Line Report Generation software,
Microsoft Office compatible
2.13.2 Test Options
Software is available for various test options (see
chapter 10).
2.13.3 Language Support
The software is configurable to English (UK),
English (US), French, German, Italian, Portugesse
and Spanish
2.14 Size and Weight
Size of system
Overall width : 500mm (19.7")
Overall height : 321mm (12.6")
Overall depth : 209mm (8.2")
Size of optional trolley (maximum)
Overall width : 720mm (28.8")
Overall height : 780mm (31.2")
Overall depth : 640mm (25.6")
Weight
System : 9.5kg (20.9lbs)
Trolley : 45kg (99.1lbs)
2.15 Operating Conditions
Temperature range : 10 – 35°C
Humidity : 25 – 95% non-condensing
2.16 Safety Standards
IEC601-1/EN60601-1 Type BF Applied Parts
EN60601-1-1
UL2601-1 Type BF Applied Parts
CAN/CSA C22.2 No.601-1-µ90 Type BF Applied
Parts
2.17 Quality Standards
CE Mark Product in compliance with the Medical
Devices Directive.
Manufactured under the following approved
Quality Management Systems :–
¨
ISO 9001:1994
¨
EN 46001:1993
¨
BS EN 46001:1994
TickIT approved procedures for software
development.
Chapter 2 Page 4 Synergy Mobile Workshop Manual
Draft March 1998 TECHNICAL SPECIFICATION

INSTALLATION AND OPERATION
BEFORE USING THE EQUIPMENT FOR THE
FIRST TIME, IT IS ESSENTIAL THAT THE
CAUTIONS AND WARNINGS BELOW ARE
READ AND UNDERSTOOD.
3.1 Operating Restrictions: Cautions
and Warnings
The cautions and warnings contained in this
Workshop Manual must be observed by the user to
ensure safe operation and to maintain the
instrument in a safe condition.
3.1.1 Attention A
The “attention” symbol Awhich appears on the
instrument means “refer to accompanying
documents”. The symbol is repeated at relevant
points in the manual and particular attention should
be paid to the marked paragraphs.
3.1.2 IEC601-1 Compliance
This equipment complies with the following
classifications according to clause 5 of
IEC601–1EN60601-1
Class I equipment
Type BF equipment
Ordinary equipment (enclosed equipment without
protection against ingress of water)
Equipment not suitable for use in presence of a
flammable anaesthetic mixture with air or with
oxygen or nitrous oxide
Mode of operation – Continuous
For full compliance of the system to the
requirements of IEC 601-1 and EN60601-1 for
Type BF ISOLATED Applied Parts, the uB
output socket is specified for the exclusive
connection of Type BF ISOLATED headphones.
Note: To comply with patient safety requirements
the PC tower, monitors and printer must be
powered from the isolated outlets of the mains
isolating transformer module as shown in the
connection diagrams.
AIf non-isolated headphones are used, the
Applied Part is classified as Type B and
there is then a non-compliance with Sub
Clause 19.2b of IEC 601-1 and EN60601-1
for SIGNAL INPUT and SIGNAL
OUTPUT PARTS and this exception
imposes restrictions on the connection of
auxiliary equipment. Under this condition
the SIGNAL INPUT and SIGNAL
OUTPUT PARTS are designated for the
exclusive connection of equipment which
complies with IEC 601-1 or EN60601-1.
Alternatively, additional external interfaces
designed to give the required protection
could be used.
3.1.3 Handbook Scope
The information contained in this Workshop
Manual should enable a qualified electronic
technician to verify the functioning of the unit, and
to fault find to board level. Some circuit details are
provided in this manual but as the majority of the
components used within the Synergy Mobile are
SMT (surface mount technology) devices, it is
strongly recommended that any defect in the
SMT circuits be rectified by board replacement.
To assist with this, fully tested replacement boards
are be available from Oxford Instruments and
principal distributors.
Schematic diagrams of the circuits are provided
with a brief description in chapter as an aid to
understanding the function of each board.
Please note that only minimal information has been
included for those boards in the Synergy Mobile
from OEM suppliers, as these have to be returned
to the suppliers for repair if a fault occurs
To resolve any queries regarding operation of the
system which cannot be resolved by consulting the
User Manual, Workshop Manual or the
applications help screens
You should consult:
¨
The approved Oxford Instruments, Medical
Systems Division subsidiary or distributor in
your country
See contact information at the front of this
manual.
INSTALLATION AND OPERATION Issue A May 1998
Synergy Mobile Workshop Manual Chapter 3 Page 1

3.1.4 Warnings
Any internal operations on the equipment should
only be undertaken by a suitably qualified
technician.
Ensure that mains fuse ratings are as shown on the
rating plate at the rear of the unit (also given in
section 3.4.4).
ANote: To comply with patient safety
requirements the PC tower must be
powered from an isolated outlet of the
mains isolating transformer module. The
Monitor and printer must also be powered
from the isolated outlets of the mains
isolating transformer module.
ANote: It is important that all applied parts
are removed from the patient before
operating the power switch or disconnecting
any of the system’s connection cables.
AThere is a danger of explosion if the
Lithium button cell on the PC motherboard
is incorrectly replaced. It must be replaced
with the same type of battery (Typically
CR2032 – 3V 170-210mAh).
Fire, explosion, and severe burn hazard. Do
not recharge, disassemble, heat above
212°F(100°C), incinerate, or expose contents
to water.
ADo not plug or unplug a stim probe or
headbox with the power switched on or
damage may result.
ANote: Only connect other electrical
equipment after consulting the
Section 3.1.5 Connecting other electrical
equipment”. Special additional protective
earthing connections are required.
When the system is in use, care must be taken to
ensure a free flow of air from the cooling slots;
under no circumstances should these slots be
obstructed in any way.
3.1.5 Connecting other electrical equipment
(For example, printers, monitors etc.)
Precautions must be taken to ensure the safety of
medical electrical equipment such as Synergy
Mobile is not adversely affected by the connection
of other electrical equipment to it.
Standard EN60601-1-1:1993 (Safety requirements
for medical electrical systems) stipulates the
necessary action(s) to be taken to ensure that
medical electrical equipment continues to comply
with EN60601-1:1990 safety requirements when
other electrical equipment is connected to medical
electrical equipment.
Any non-medical equipment connected to a
medical electrical system should comply with an
appropriate safety standard, for example EN60950,
UL1950.
Synergy Mobile is fitted with a mains isolating
transformer module in the base of the trolley
designed to meet the safety requirements of
EN60601-1:1990, UL2601-1:1994, CSA 22.2
No. 601.1 M90.
This transformer has the capacity to supply other
electrical equipment used with Synergy mobile in
addition to the basic Synergy mobile components
(i.e. the PC tower and display monitor). The
transformer can typically also supply a small laser
printer such as the HP Laserjet 6L and a second
colour monitor for visual EP stimulation. If
equipment not supplied by Oxford Instruments is
to be connected to the isolating transformer outlets
then the user must check before connecting that the
maximum power output available from the
transformer will not be exceeded.
If other electrical equipment powered from a wall
socket outlet rather than via the Synergy mobile
isolating transformer is to be connected to Synergy
mobile then standard EN60601-1-1:1993 “Safety
Requirements for Medical Electrical Systems”
should be consulted to determine the appropriate
actions necessary to ensure safety for a particular
installation.
Two examples of medical electrical systems
meeting EN60601-1-1 requirements are shown on
the following pages.
However it must be emphasised that these are only
examples and every installation must be
individually checked for compliance with
EN60601-1-1 and the appropriate actions taken to
ensure patient and user safety is maintained.
Issue A May 1998 INSTALLATION AND OPERATION
Chapter 3 Page 2 Synergy Mobile Workshop Manual

INSTALLATION AND OPERATION Issue A May 1998
Synergy Mobile Workshop Manual Chapter 3 Page 3
DSP
Network
Sound
EP Stim
PC Tower
Isolating Transformer & PSU
Footswitch
Connection Unit
a
2
8
t
B
u
t
A
W
VGA & Mono
EP Microphone
External stim input
L/R line output
Trigger in / out
Aux Ext Stim
E
Headbox
10 Ch 031C003
2 Ch 031C001
5 Ch 031C002
Control Panel
034C001
Monitor with
Multimedia speakers
L
R
RR L
Mains input from
SIGNAL
Stim electrode
PX
Connections
*
*
*
View on front
lower bay of
PC tower
Serial port
USB
port
034A002
or
034A003
Stim Probe
031K025
034C002
034S016
034D014
034D007
034D005
034D006
034S003
PS1285
EP Audio
Output
OR INDICATE OPTIONAL
PARTS
DC Power to Tower
isolating transformer
Mains wall
outlet socket
EMG Speaker
SK26
EMG
Synergy Mobile System Configuration
and connections
Printer
u
Isolated mains outputs

Issue A May 1998 INSTALLATION AND OPERATION
Chapter 3 Page 4 Synergy Mobile Workshop Manual
Synergy mains
cable including
protective earth
Other equipment mains
cable including protective
earth
Other electrical
equipment
Signal
cable
MEDICALLY USED ROOM
Synergy
Wall outlet
sockets
CAUTION - The other electrical equipment must not be in the
patient vicinity if it is non-medical equipment.
Example A
Example A - Both Synergy and the other electrical equipment have separate protective earth
connections to wall socket outlets in the medically used room to prevent allowable leakage
currents being exceeded in the event of the failure of either protective earth connection.
Portable multiple socket outlets be used.
must
separate
must not
NO !
PC tower
Printer
Monitor
Isolating
transformer
Mains inlet
Isolated mains
outlets

INSTALLATION AND OPERATION Issue A May 1998
Synergy Mobile Workshop Manual Chapter 3 Page 5
Example B - Both Synergy and the other electrical equipment are connected to the local protective
earth in their respective rooms. As the may be a potential difference between the protective earths
in the two rooms Synergy requires a second separate protective earth connection in the medically
used room to prevent allowable leakage currents being exceeded in the event of failure of the first
Portable multiple socket outlets be used.must not
protective earth to Synergy.
NO !
Synergy mains
cable including
protective earth Other equipment mains
cable including protective
earth
Signal
cable
Example B
MEDICALLY USED ROOM
Synergy
Wall outlet
socket
PC tower Printer
Monitor
Isolating
transformer
Mains
inlet
Isolated mains
outlets
Other electrical
equipment
OTHER ROOM
Signal
cable
Wall outlet
sockets
Additional protective
earth conductor
connected between
the metalwork of the
Synergy mains
isolating transformer
module and the earth
pin of a
wall socket in the
medically used room
separate
Additional protective
earth point

3.1.6 Warning and Other Symbols
Certain important functions are identified by
pictographs as follows:–
sProtective Earth (used internally only)
YFunctional Earth (Ground)
dAlternating Current
AAttention, Consult accompanying
Documents
fDanger High Voltage
eType BF. The IEC 601-1 symbol for type
BF equipment with isolated applied parts.
BType B. The IEC601-1 symbol for type B
equipment.
3.2 Disclaimer
Oxford Instruments considers itself responsible for
the effects on safety, reliability and performance of
the equipment only if :–
Modifications and repairs are carried out by
persons expressly authorised by Oxford
Instruments .
The equipment is used in accordance with the
instructions in the User Manual or this Workshop
Manual.
3.3 Signal Cables
High quality screened cables must be used when
connecting to the auxiliary input/output connectors
of Synergy mobile to ensure compliance with
EMC regulations. Braid screened or double
screened (braid plus foil) cables are the preferred
types. The cable screen should make a 360°
connection to the screening shells of the
connectors on each end of the cable.
3.4 Installation
3.4.1 Inspection
Check that there are no obvious defects or damage
to the PC tower, Isolation transformer / Power
Supply, the amplifier, control box any other cables
or accessories.
3.4.2 Mains Supply Cable
Check that the mains supply cable is fitted with a
shrouded 3-pin mains connector (female) which
mates with the appliance inlet at the back of the
Isolation transformer / Power Supply.
Check that the free end of the mains supply cable
is fitted with a suitably rated mains plug having
protective earth connection. The wires are colour
coded as follows:
Brown = Line
Blue = Neutral
Green/Yellow = Protective Earth
It is essential that the protective earth conductor is
connected to an external protective earth system to
ensure patient safety and correct operation of the
unit. This protection is automatic in three-wire
mains systems if the mains plug has been correctly
wired.
3.4.3 Voltage selectors
It is vital to set the mains selector switches on the
Isolation transformer / Power supply for the
local mains voltage. The switch marked Imust
be set to suit the mains input voltage 100V-120V
or 200V-240V. The Xswitch sets the output
voltage of the six isolated mains outlets
100V-120V or 200V-240V. Both switches must be
set to the same voltage. The switches can be
altered by removing the two screws that secure the
cover plate.
Set the switches as required then the cover plate is
refitted.
The label adjacent to the switches indicates the
required settings.
It is vital to set the mains input selector switch
on the PC tower for the local mains voltage 115V
or 230V. This selector switch is located above the
mains inlet on the back of the PC tower.
Note :- Some PC towers made by HP may not
have a mains input selector switch. These units
have a mains voltage auto sensing and selection
circuits for mains voltages from 100-127V and
200-240V.
3.4.4 Fuses Isolation transformer / Power
supply
Check that the value of mains fuses F1 and F2, is
correct for the local mains voltage. The fuses are
located on the Isolation transformer / Power supply
just below the main on / off switch. The label
adjacent to the fuses indicates the required rating
for the mains voltage. The ratings are shown in the
following tables.
Issue A May 1998 INSTALLATION AND OPERATION
Chapter 3 Page 6 Synergy Mobile Workshop Manual

Mains fuses for Power Supply
Mains Voltage F1/F2 Fuse Rating
100-120V T10A L 250V
20mm ×5mm
200-240V T6.3A L 250V
20mm ×5mm
Fuses are LOW BREAKING CAPACITY type
To change the fuses, switch off the Synergy
mobile, disconnect the mains supply, unscrew the
caps on the fuse holders F1/F2 and withdraw
fuses from holders. When the correct fuses have
been inserted in the holders, refit and screw them
back into position in the power supply.
If any fuse fails shortly after replacement, a fault is
indicated and a qualified electronic technician
should be consulted to trace and repair the fault.
3.4.5 Keyboard and Mouse
The keyboard and mouse have PS/2 type mini-DIN
connectors on the leads which mate with the
sockets on the PC tower marked 2and 8
respectively. See The leads must be connected to
the mainframe before switch-on for the system to
recognise them.
3.4.6 Control panel
This connects to the PC tower via the K1 socket
on the connection unit.
3.4.7 Connection unit
This provides a method of connecting the control
panel, foot swtich, stimulator probes, control unit,
speaker, trigger signals, headphones to the PC
tower via leads 034D005 and 034D007.
3.4.8 PC I/O panel
The is mounted in the lower front section of the
tower. This panel connects and switches the
isolated DC power from the PSU to the EMG and
EP stimulator cards in the PC tower. Also provides
connection for all the other signals that are handled
by the connector unit and control panel.
3.4.9 Foot switch
The Foot switch has a 9 Way D type plug which
connects to a socket marked 9on the connection
unit.
3.4.10 Printer
The data lead from the printer must be connected
to the socket on the PC tower marked q. This is
a 25 way D-type socket connected directly to the
motherboard.
3.4.11 Headbox
The headbox is supplied with a detachable lead to
connect it to the mainframe. The lead has a
moulded high density SCSI connector at each end
to connect to the headbox and the DSP connector
on the rear of the PC tower. This type of socket
has longer pins on the four corners and in the
Synergy Mobile these are connected to 0V, which
means that when the headbox is plugged in the 0V
connections are made before any of the others.
3.4.12 Headphones
If the system has an EP Stimulator installed, the
headphones should be plugged into the 5 pin DIN
socket marked uB on the connection unit for
performing auditory tests.
3.4.13 Visual Stimulus Monitor
If the system has an EP Stimulator installed, the
Visual EP stim monitor should be plugged into the
socket marked W. See Figure 3-1 Connections to
Rear Panel of PC Tower. If using a non-SVGA
monitor then an adapter lead will be required to
suit your monitor. The type of monitor can be set
in the System Configuration menu. VEP video
standard. can be SVGA, 625, 525 or 100Hz.
3.5 Routine Maintenance
AON NO ACCOUNT SHOULD THIS
EQUIPMENT BE AUTOCLAVED OR
STERILISED BY EXPOSURE TO HEAT,
RADIATION OR ANY FLUID.
3.5.1 Cleaning the unit and trolley.
The covers and any plastic mouldings may be
wiped clean with a dry, lint-free cloth, blown free
of dust with a low-pressure airline or carefully
cleaned with a suitable vacuum cleaner. Stubborn
greasy dirt on the case and panels may be wiped
off using a damp cloth moistened with a little mild
detergent (washing-up liquid). On no account
should any liquid be allowed to enter the case.
The System uses solid state components and little
routine maintenance is required.
If a fuse should fail, see subsection 3.4.4. If the
fuse fails again indicating a fault condition,
You should consult:
¨
The appointed Oxford Instruments subsidiary
or distributor in your country.
See contact information at the front of this
manual.
INSTALLATION AND OPERATION Issue A May 1998
Synergy Mobile Workshop Manual Chapter 3 Page 7

3.6 Controls
To simplify operation, the number of controls has
been minimised.
The functions of these controls is listed below.
VOLUME
This rotary control adjusts the
volume of the audio output
from the external
loudspeaker.
TRIGGER
LEVEL
This rotary control adjust the
vertical position of the trigger
point. It operates in parallel
with the trigger control on the
headbox. A push-button on the
shaft acts as a “Trigger
On/Off” control.
TRIGGER
POLARITY
+/- SWITCH
This push button control
selects whether the signal is
being triggered on the positive
or negative going edge. This
switch is only useable in
Signal Trigger mode.
SENSITIVITY
This rotary control adjusts the
Display Sensitivity of the
selected trace(s) and operates
in parallel with the sensitivity
control on the headbox.
SWEEP
DURATION
This rotary control adjusts the
Sweep Duration of the
selected channel(s) and
operates in parallel with the
sweep duration control on the
headbox.
ACQUIRE
ON SWITCH
Pressing this switch to sets
acquire “ON”. Pressing again
will turn acquire “OFF”
ACQUIRE
SINGLE
SWITCH
Press this briefly once to
deliver a stimulus and acquire
a response. Pressing and
holding the switch for more
than one second will lock
acquisition“ON”. If acquire is
already latched on, pressing
either switch will turn acquire
off.
This control operates in
parallel with acquire on the
stimulus probe.
ERASE
Pressing this button erases the
selected trace(s) but may
depend on the system mode.
Results associated with the
trace(s) will also be erased.
Press this switch to erase the
selected trace or traces. This
enables you to collect a fresh
set of data in the same store.
STIMULUS
DURATION
This rotary switch is used to
increment or decrement the
duration ( pulse width ) of the
EMG stimulus.†
STIMULUS 1
INTENSITY
SWITCH
This rotary control is used to
set the intensity of the
electrical stimulus pulse for
the internal EMG stimulator
(or external stim probe A if
fitted) .†
STIMULUS 2
INTENSITY
SWITCH
This rotary control is used to
set the intensity of the
electrical stimulus pulse for
the internal EMG stimulator
(or external stim probe if
fitted) .†
STIM
Pressing this button turns the
stimulus on, without acquiring
patient data.†
NEXT
Pressing this button, retains
the current data, and selects
the next store(s) ready for data
acquisition. Use to move to
the :
Next site in NCV or EMG
tests and next run in EP tests.
† The control panel stimulator controls will not
function if there are two external stimulators
installed and the test being used is configured to
use both stimulators e.g. “Collision” tests. If an
external “Stim A” probe is being used on its own,
the controls on the probe and on the control panel
will function in parallel.
Issue A May 1998 INSTALLATION AND OPERATION
Chapter 3 Page 8 Synergy Mobile Workshop Manual
Table of contents
Other Oxford Medical Equipment manuals