Installation Guide
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Installation Guide
MedelecSynergy EMG and EP Systems Part Number: 55-040W004-E
VIASYS Healthcare UK Ltd
VIASYS Healthcare
Manor Way Old Woking Surrey, GU22 9JU United Kingdom Tel: + 44 (0) 1483 770331 Fax: + 44 (0) 1483 727193
5225 Verona Road, Building 2 Madison, WI 53711-4495 USA Tel: +1 800 356 0007 (US Only) Tel: +1 608 273 5000 (International) Fax: +1 608 441 2004 Email: [email protected]
www.viasyshealthcare.com The Synergy range of multimedia EMG/EP systems has been designed and manufactured by Viasys Healthcare, an international company that has always had an enviable reputation for innovation and quality of its products. VIASYS Healthcare has been certified by Lloyd’s Register Quality Assurance (LRQA) as an approved medical devices manufacturer as meeting the requirements of BS EN ISO 9001, BS EN 46001 and the Medical Devices Directive (93/42/EEC). The Synergy range of multimedia EMG/EP systems has been independently tested and successfully approved to the following medical safety standards: IEC 60601-1, EN 60601-1, UL 2601-1, CAN/CSA-C22.2 No. 601.1, JIS T 0601-1 or JIS T 1001/1002, IEC 60601-1-1, EN 6060 1-1-1, JIS T 0601-1-1, IEC 60601-1-2, EN 60601-1-2, IEC 60601-240, EN 60601-2-40. The Synergy range of multimedia EMG/EP systems is CE Marked in accordance with the European Council Directive 93/42/EEC concerning medical devices. The Synergy range of multimedia EMG/EP systems bears the ETL Listing Mark, which is a Nationally Recognised Testing Laboratory (NRTL) Mark in the United States and Canada. Indicates that this product comes under the provisions of EU Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) and that this unit was placed on the market after 12th August 2005. This directive covers EOL (End-of-Life) disposal. Within the EU, at end-of-life, this product may only be disposed of through a government approved collection scheme or treatment facility. If in doubt contact your local VIASYS Healthcare representative
Copyright All rights reserved. This manual contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written permission of VIASYS Healthcare. The copyright and the foregoing restrictions on the copyright use extend to all media in which this information may be preserved. This copy of the User Manual shall be used only in accordance with the conditions of sale of VIASYS Healthcare or its distributors. VIASYS Healthcare makes no representations or warranties of any kind whatsoever with respect to this document. VIASYS Healthcare disclaims all liabilities for loss or damage arising out of the possession, sale or use of this document. Medelec and TECA are registered trademarks of VIASYS Healthcare in the UK and other countries. EMG LivePlay™ and LongTrace™ are trademarks of VIASYS Healthcare. Microsoft Office, Windows and NetMeeting are registered trademarks of Microsoft Corporation. Intel Pentium and Centrino are registered trademarks of INTEL Corporation.
CAUTION: Federal Law restricts this device to sale by or on the order of a physician.
Table of Contents Table of Contents
4
Introduction
1
The Synergy products Safety Safety considerations Responsibility of the manufacturer Cautions and warnings Disposal of equipment Symbols and their definition Connections Mouse, keyboard and monitor Control Panel connections 2, 5 and channel amplifiers Stimulator options Footswitch Speaker unit or junction box (Synergy T2 and N2) Headphones Display monitor (tower PC systems) Printer (option) Visual stimulator monitor (option) Installation Checks Environment Power supply connections Power connections to Synergy Connecting other electrical equipment Electromagnetic Compatibility (EMC) Synergy N2 and T2 PIU EMG systems Electromagnetic emissions: guidance to user Electromagnetic immunity Guidance to user (1) Guidance to user (2) Separation distances for RF communications equipment Synergy N and T Plinth EMG/EP/IOM systems Electromagnetic emissions: guidance to user Electromagnetic immunity Guidance to user (1) Guidance to user (2) Separation distances for RF communications equipment Electrical interference
1 15 15 17 19 19 20 23 23 24 25 25 26 27 29 29 29 30 33 33 34 34 36 37 38 39 40 41 41 43 44 45 47 48 48 50 51 52
Synergy software setup
55
Set up report header
55
Set up report signature Set up patient demographics Set up visit information Customise the muscle list Customise the EMG Summary Table To modify your test setup Back up system settings Network setup Cautions Setting up the Synergy server Set up Synergy users within the Windows environment Connecting Synergy systems to the LAN
55 55 56 56 56 56 57 59 59 60 61 61
Interface connections
63
Technical specifications
65
Synergy N and Synergy T systems Synergy N2 and T2 systems Appendices Appendix A Trolley assembly for Synergy T series Appendix B Trolley assembly for Synergy N Appendix C Trolley assembly for Synergy T2 and N2 Appendix D System interconnection diagrams for Synergy N and T Appendix E System interconnection diagrams for Synergy N2 and T2
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Synergy Installation Guide
Introduction This Installation Guide is intended as a guide to installing and setting up your Synergy system before using it for the first time. For further information, refer to the following: Information
Use
Part number
Installation Guide User Guide
First time use For day-to-day use. Includes descriptions of the hardware.
040W004 040W009
Synergy Online Help
Quick reminder of test methods in Synergy software
N/A
Reference Manual
System configuration and application information, more detailed and alternative test methods.
040W002
Administrator's Guide
For advice on networking and patient data protection
040W027
Service Manual
For detailed servicing advice
040W003
Accessories Catalogue
For advice on accessories
The Synergy products The Synergy systems are 2/5/10-channel neurodiagnostic systems, which provide facilities for Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potential (EP) recordings and Intra-Operative Monitoring (IOM), for a range of clinical applications. Synergy is available as Synergy N2 and T2 (PIU based, 2 channels, suitable for NCS and EMG only) and the Synergy N and Synergy T Series (Plinth based, 2, 5, and 10 channels, suitable for NCS, EMG, EP and IOM).
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Synergy Installation Guide
Synergy N2 and Synergy T2 These systems comprise a Notebook or Tower PC, together with a PIU (integral 2-channel amplifier and electrical stimulator). Synergy N2
Synergy T2
The systems comprise the following standard and optional items: Item
N2
Multimedia Notebook PC with internal Network Card, modem, CD-Writer, medical grade psu, Microsoft Windows and Office, Synergy software, optional mouse
Multimedia Tower PC with internal Network Card and CD-Writer, keyboard, mouse, Microsoft Windows and Office, Synergy software
T2
CRT monitor or LCD monitor Single footswitch * see 2/5/10 channel EMG/EP
PIU with integral 2-channel amplifier and electrical stimulator *
Deluxe Stimulator Probe *
Desk mount for PIU
Mains isolating transformer module
Temperature probe
Trolley and arm
Arm and desk mount
Carry case
Printer
PC to PC Network cable
External loudspeaker
= standard; = optional
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* see below for more detail
Synergy Installation Guide
Patient Interface Unit
The Patient Interface Unit (PIU) provides single control operation for setting essential parameters during a patient examination.
A
Stim
This switch toggles Stimulus ON and OFF. If Acquire is ON, pressing this switch has no effect.
B
Next
Press this switch to move to the next site in NCS and EMG tests.
C
Volume
Rotate this switch to change the level of the audio output of the input signal. Set it to zero for no audio output.
D
Sensitivity
Rotate this switch to adjust the display sensitivity of the selected trace or traces. If no trace is selected (to deselect a trace click away from it), the sensitivity of all the traces in the current test is changed.
E
Socket for Deluxe Stimulator Probe
F
Sweep Duration
Rotate this switch to adjust the acquisition sweep duration for the active trace(s). Once data has been acquired you can also increase or decrease the sweep duration for selected traces.
G
Erase
Press this switch to erase the selected trace or traces. This enables you to collect a fresh set of data in the same store.
H
Socket for footswitch
I
Fn1
Programmable via the Display menu to control Marker, Trigger or Cursor.
J
Fn2
Programmable via the Display menu to control Averager On/Off, record cursor, trigger polarity, EMG Staging.
K
Stim Duration
Rotate this switch to adjust the duration (pulse width) of the stimulus.
L
Acquire ON
Press this switch to set acquire ON. Press it again to set Acquire OFF.
M
Acquire Single
Press once to deliver a stimulus and acquire a response. If you hold down this switch for more than 1 second, Acquisition is locked on. Press again to stop Acquisition.
N
Stim Intensity
Use this switch to adjust the amplitude of the stimulus. Stim Intensity is displayed in the Toolbar.
O
On / off
P
Socket for Temperature Probe
Q
Ground socket
R
DINs and inputs for electrode connections
S
Internal stimulator connections
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Synergy Installation Guide
Deluxe Stimulator Probe Your system will have a choice of two types of stimulators. One stimulator is internal with an output on the PIU or control panel. The second stimulator is the Deluxe Stimulator Probe.
The Deluxe Stimulator Probe enables you to control the following: A
Stim ON / OFF
Push to deliver a stimulus without acquiring data. This button turns the stimulus ON and OFF. If all stimuli are OFF when you push the button, stimulus is set ON. If Acquire is ON, pushing this button has no effect.
B
Next switch
Push to move to the next site and start a new acquisition.
C
Stimulus Polarity
Push to change the polarity of the stimulus: the negative probe tip changes to negative and the negative probe tip changes to positive. Note that the positive probe tip has its LED lit.
D
Stim Intensity / Acquire
Rotate to adjust the amplitude of the stimulus. Stim Intensity is displayed in the Toolbar. Push to deliver the stimulus and acquire the data.
E
Stim Duration Up / Down
Push the up (left) or down (right) button to increase or decrease the duration (pulse width) of the stimulus.
With the adjustable head, you can modify the Deluxe Stimulator Probe for paediatric use: 1 Unscrew the probe tip C (next to the locking button A). 2 Screw this tip into position B. Note: do not force the probe tips when you move them. Always slide down the locking button before you attempt to release them.
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Synergy Installation Guide
Medical Grade Power Supply On Synergy T2 systems, the medical grade power supply powers the PIU and speaker unit; on Synergy N2 systems, it powers the PIU and notebook, and the optional speaker unit. CAUTION: Use the medical grade power supply 070S001 whenever you are using Synergy with a patient. Note: On Synergy N2 systems, the notebook power supply unit is also shipped. The notebook power supply can be used if you are running your notebook as a standalone PC, but never use it when the PC is connected to the Synergy system. CAUTION: The medical power supply 070S001 must only be used to power the model of notebook PC supplied with your Synergy system. Do not attempt to use it with any other model of notebook PC.
Speaker Unit As well as providing audio output for EMG tests, the speaker unit routes power to the PIU (and the notebook when used on Synergy N2 systems). The speaker unit is supplied with a two-piece pull-apart fastener, with selfadhesive pad, as a separate item. Use this if you want to attach the speaker unit to the trolley. Note: There are two clips on the rear of the speaker unit that can be used to retain cables.
Junction Box On Synergy N2 systems that do not have the optional speaker unit, a junction box is supplied to route power from the medical grade power supply to the PIU and notebook. The junction box is fitted with a two-piece pull-apart fastener, with self-adhesive pad, to attach the junction box in the desired position on the trolley.
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Synergy Installation Guide
Isolation Transformer All parts of the Synergy T2 and T Plinth systems must be powered from the outlets of the ISO-1000VA mains isolation transformer.
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Synergy Installation Guide
Synergy N and Synergy T Series These systems comprise a Notebook or Tower PC, together with a Plinth, patient side control panel, and 2, 5, or 10-channel amplifier. Synergy N Series
Synergy T Series
The systems comprise the following standard and optional items: Item
N Series
Multimedia Notebook PC with internal Network Card, modem, CD-Writer, DC to DC adapter, Microsoft Windows and Office, Synergy software, optional mouse
T Series
Multimedia Tower PC with 1 7” OR 1 9” flat panel display, internal Network Card and CD-Writer, keyboard, mouse, Microsoft Windows and Office, Synergy software
Plinth *
2/5/10 channel amplifier *
Control panel
Deluxe Stimulator Probe *see 2 channel EMG section
Footswitch (Single or triple) *
Mains isolating transformer module
Temperature probe
Trolley and arm
Arm and clamp
Rolling case
Printer
PC to PC Network cable
I/O Interface Unit
Patient Side Headbox
IOM Stimulator
Extension Surgeon Footswitch
= standard; = optional
* see below for more detail
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Synergy Installation Guide
Plinth The Plinth contains connections to the amplifier, stimulators and PC interfaces. It links together the PC, amplifier, control panel and accessories. It also has connections to power the Notebook.
Rear of Plinth
Left side of Plinth Rear of Plinth:
Left side of Plinth:
A
O I
On/Off switch
L
B
Mains lead connector
M
EMG
EMG external speaker interface
C
DC to DC power adaptor for connection to Notebook
N
EMG
Headphones for EMG
D
PC
Connection to PC Audio (yellow)
O
EP
Microphone for Auditory EP *
E
Footswitch interface (orange)
P
EP
Auxiliary input for Auditory EP *
F
Control panel interface (brown)
Q
EP
Headphones for Auditory EP *
G
External trigger port
H
PC USB interface
Two interfaces for up to two Deluxe Stimulators or a single IOM Stimulator (light grey)
J
Amplifier interface (black)
K
Functional earth connection
I
Speaker for EMG
* These connections are not available on EMG -only systems
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Synergy Installation Guide
Plinth (continued)
R
S
Right side of Plinth Right side of Plinth
Front of Plinth (not shown):
R
Visual EP LED goggles interface *
Green light
S
Visual EP monitor interface *
Indicates the Plinth has power
Speaker for EMG * These connections are not available on EMG-only systems
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Synergy Installation Guide
Control panel The control panel provides a single control operation for setting essential parameters during a patient examination. It includes a mouse capability.
A
Fn1
Programmable via the Display menu to control Marker, Trigger or Cursor.
B
Fn2
Programmable via the Display menu to control Averager On/Off, record cursor, trigger polarity, EMG Staging.
C
Volume
Rotate to change the level of the audio output of the input signal. Set it to zero for no audio output.
D
Sensitivity
Rotate to adjust the display sensitivity of the selected trace or traces. If no trace is selected (to deselect a trace click away from it), the sensitivity of all the traces in the current test is changed.
E
Next
Push to move to the next site in NCS and EMG tests.
F
Sweep Duration
Rotate to adjust the acquisition sweep duration for the active trace(s). Once data has been acquired you can also increase or decrease the sweep duration for selected traces.
G
Erase
H
Acquire ON/OFF
Push to erase the selected trace or traces. This enables you to collect a fresh set of data in the same store. Push to set acquire ON. Press it again to set Acquire OFF.
I
Acquire Single
Push once to deliver a stimulus and acquire a response. If you hold down this button for more than 1 second, Acquisition is locked on. Push again to stop Acquisition.
J
Stim B
Rotate to adjust the amplitude of the external stimulus, the Deluxe Stimulator. Stim Intensity is displayed on the tool bar and also on the Status Panel.
K
Green light
Indicates the control panel has power.
L
Stim On/Off
Push to toggle Stimulus On and Off, without acquiring. If Acquire is On, pushing this button has no affect.
M
Stim Duration Stim A
Rotate to adjust the duration (pulse width) of the stimulus. Rotate to adjust the amplitude of the internal stimulus. Stim Intensity is displayed on the tool bar and also on the Status Panel.
N O
Internal Stimulus Inputs
P
Right button
Push to open a menu
Q
Pointing device
Push to move pointer on screen.
R
Left button
Push to select
On rear of control panel
Removable clip for attachment of the control panel to a bedside, blanket, desk, keyboard on mouse tray of the trolley
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Synergy Installation Guide
Amplifier 2 channels The amplifier provides control over the signal from the electrodes, as well as amplifying and digitising it. The two-channel amplifier has 2 positive, 2 negative and 1 neutral 1.5mm touchproof connections
A
Sensitivity Control
Use this to adjust the display sensitivity of the selected trace or traces. If a trace is not selected, the sensitivity of all the traces in the current test is changed.
B
Impedance check ON button Two-channel Impedance Check indicators
Push this button to show impedance levels.
D
Amplifier ON/OFF switch
Use this to switch the amplifier ON and OFF.
E
Temperature Probe Input
An input for a temperature monitoring probe.
F
Sweep Duration Control
G
Trigger Control
Use this to adjust the acquisition sweep duration for the selected trace(s). Once data has been acquired you can also increase or decrease the sweep duration for selected traces. If no trace is selected (deselect a trace by clicking away from it) all traces are affected. Use this to set the trigger level for signal trigger mode. The trigger level takes effect when you select signal trigger acquisition mode.
H
2 DIN sockets
I
Ground socket
C
The impedance level (<2, 4, 8, 16, 32 and >32 KOhms) is shown for each input when the appropriate button is pressed.
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Synergy Installation Guide
Amplifier 5 channels The amplifier provides control over the signal from the electrodes, as well as amplifying and digitising it. The five/ten-channel amplifier has 20 1.5mm connections: 12 cephalic in 10-20 format, 6 non-cephalic and 2 neutral.
A B
Temperature Probe Input
An input for a temperature monitoring probe.
Sensitivity Control
Use this to adjust the display sensitivity of the selected trace or traces. If a trace is not selected, the sensitivity of all the traces in the current test is changed.
C
Sweep Duration Control
Use this to adjust the acquisition sweep duration for the selected trace(s). Once data has been acquired you can also increase or decrease the sweep duration for selected traces. If no trace is selected (deselect a trace by clicking away from it) all traces are affected.
D
Impedance Pass Level Up/Down buttons
These are used to set the impedance level. The Impedance Check indicator is illuminated for any channel that fails the impedance check.
E
Five -channel Impedance Check indicators
F
Amplifier ON/OFF switch
These are the LEDs for the inputs. With the amplifier on, the LEDs indicate which electrodes are in use. When Impedance is on, the LEDs indicate high impedance if they are lit. Use this to switch the amplifier ON and OFF.
G
Trigger Control
H
2 DIN sockets
I
Ground socket
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Use this to set the trigger level for signal trigger mode. The trigger level takes effect when you select signal trigger acquisition mode.
Synergy Installation Guide
Footswitch Th ere is a single and triple footswitch available. The single footswitch has function C Acquire only. (Single footswitch not shown.)
A
Programmabl e
The function of this switch is specific for each test. If you have the optional Test Configuration Wizard, you can configure this switch.
B
Next
Click the footswitch icon in the toolbar to display the function you have allocated to this footswitch. For NCV and Needle EMG tests: Push once to move to next store.
C
Acquire
For EP tests only: Push once to move to next run. Push once to deliver a stimulus and acquire a response. If you hold down this switch for more than 3 seconds Acquisition is locked on. Push again to stop acquisition.
Isolation Transformer All parts of the Synergy T2 and T Plinth systems must be powered from the outlets of the ISO-1000VA mains isolation transformer.
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Synergy Installation Guide
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Synergy Installation Guide
Safety Safety considerations The Synergy system complies with IEC 60601-1, the International standard for safety for medical electrical equipment: Class 1 Type of protection against electrical shock Degree of protection against electrical shock
Type BF
Degree of protection against harmful ingress of liquid
Ordinary (no protection)
Mode of operation
Continuous
Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide
Not suitable
The Synergy system also complies with: IEC 60601-1-1: European standard for medical electrical systems IEC 60601-1-2: European standard for electromagnetic compatibility requirements for medical electrical systems IEC 60601-2-40: European standard specifying particular safety requirements for EMG and EP equipment UL2601-1: American standard for safety for medical electrical equipment CAN/CSA C22.2 No.601.1: Canadian standard for safety for medical electrical equipment JIST06001-1: Japanese standard for safety for medical electrical equipment
CE Mark The product is CE marked to show our products meet the full requirements of the European Medical Device Directive.
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