MedelecSynergy Multimedia EMG User Manual Vs8.0

Oxford Instruments Medical Ltd Manor Way, Old Woking Surrey, GU22 9JU, UK Tel: +44 (0)1483 770331 Fax: +44 (0)1483 727193 E-Mail: [email protected]

!

www.oxford-instruments.com 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 Oxford Instruments Medical Ltd. 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 Oxford Instruments Medical Ltd or its distributors. Oxford Instruments Medical Ltd makes no representations or warranties of any kind whatsoever with respect to this document. Oxford Instruments Medical Ltd 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 Oxford Instruments Medical Ltd in the UK and other countries.

This product complies with the provisions of the Medical Device Directive (93/42/EEC) FRANCE Oxford Instruments SARL Domaine Technologique de Saclay Bátiment Ariane 4 rue René Razel 91892 SACLAY Cedex Tel: +33 (1) 69 85 25 00 Fax:+33 (1) 69 85 25 09 E-Mail: [email protected] GERMANY Oxford Instruments Medical GmbH Otto-von-Guericke-Ring 10 65205 Wiesbaden Postfach 4509, D-65035 Wiesbaden Tel: +49 (0)6122 937-0 Fax: +49 (0)6122 937-100 E-Mail: [email protected] NETHERLANDS Oxford Instruments Medical NV Avelingen West 1 4202 MS Gorinchem Tel: + 31 (0) 183 692111 Fax: + 31 (0) 183 6 92119 E-Mail: [email protected]

ITALY Oxford Instruments Medical Spa Via Leone Tolstoi, 86 20098 San Giuliano Milanese Milano Tel: +39 (0)2 982 531 Fax:+39 (0)2 982 41407 E-Mail: [email protected] SPAIN Oxford Instruments Medical SA Avda. Mata Pinõnera 2 28700 San Sebastian de los Reyes Madrid Tel: +34 (91) 653 8198/ 8387/ 8398 Fax: +34 (91) 654 6794 E-Mail: [email protected] BELGIUM Oxford Instruments Medical NV Molenberglei 21 B-2627 Schelle Tel: + 32 (0) 3 880 82 80 Fax: + 32 (0) 3 844 78 42 E-Mail: [email protected]

TECASynergy Multimedia EMG

Notebook, Tower and Suite User Manual 035W001B Vs8.0

Oxford Instruments Medical Inc. 12 Skyline Drive, Hawthorne, New York 10532-2133, USA

Oxford Instruments Medical Ltd Manor Way, Old Woking, Surrey, GU22 9JU, UK

Tel: +1 914 593 7100 1-800 438-8322 Fax: +1 914 593 7290 E-Mail: [email protected]

Tel: +44 (0)1483 770331 Fax: +44 (0)1483 727193 E-Mail: [email protected]

www.oxford-instruments.com

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 Oxford Instruments Medical Ltd. 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 Oxford Instruments Medical Ltd or its distributors. Oxford Instruments Medical Ltd makes no representations or warranties of any kind whatsoever with respect to this document. Oxford Instruments Medical Ltd 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 Oxford Instruments Medical Ltd in the USA.

Caution: Federal law restricts this device to sale by, or on the order of a physician

SYNERGY USER MANUAL

Contents Using this Manual ...viii Safety and symbols...ix Safety considerations...ix Caution and warnings...x Responsibility of the manufacturer ...x Disposal of equipment...xi Electrical interference suppression...xi Sources of artefact...xii

Symbols and their definition ... xiii Information...xiii Connections...xv Switches ...xvii Warning Symbols...xvii

1: Overview of the system... 1 The System and its parts...1 Components of the Synergy Notebook ...4 Components of the Synergy Tower...6 Components of the Synergy Suite...8 The Patient Interface Unit ...9 Footswitch...11 Deluxe Stimulator Probe...12

Using Synergy...14 Logging onto the system ...14 Components of the GUI ...15 Opening and closing folders...16 Using Electronic Mail ...16 Getting support...16

Synergy Reader Software ...17 Configuring the System ...18 The Patient Database ...19 The Tests ...20 Generating Reports...21

2: Handling Patient Information ... 23 Entering and saving patient information...23 Entering and saving a new patient...24 Entering and saving visit details...25

Retrieving existing patient information ...27 ii

INTRODUCTION

Recalling a patient...27 Deleting a patient ...27

Transferring patient information between Synergy systems...28 Transferring patient data between host and satellite...28 Using Transfer to transfer patient data between systems ...28 Using Copy to transfer patient data between systems ...29 Completing the Transfer...30

Reviewing results and reports for an existing patient ...31 Recalling an existing patient ...31 Opening the Test Catalog ...31 Recalling results using the Test Catalog ...33 Viewing results in the Test Catalog...33 Deleting results...33

Searching for patient information ...35 Searching on patient details...35 Clearing the Search Criteria dialog box ...35 Cancelling a search...35

Saving and loading patient and report data to file ...36 Saving patient and report data to file...36 Loading patient and report data from File ...37

3: Generating reports ... 39 Overview...39 Obtaining a report online ...40 Selecting an online report...41 Viewing a report...41 Adding comments ...41 Recompiling a report...41

Recalling a report ...43 Opening a report in Microsoft Word ...43 Opening a report in MedPad ...43 Editing and saving a report using MedPad...43

Customising the report layout ...44 Selecting and defining a header file ...45 Selecting and defining a signature file ...46 Defining the report sequence and inserting page breaks ...47 Defining Test Report settings...47

Printing a report ...48

4: Configuring the system ... 49 System configuration ...49 Defining the host and satellite...50 Defining a system as a host ...50 iii

SYNERGY USER MANUAL

Defining a system as a satellite ...50 Configuring an E-mail program ...51 Selecting a Notch Filter Setting ...51 Configuring Patient Demographics...52 Setting up a new user ...52 Editing a user's set-up ...53 Deleting a user ...54

User Configuration...55 Changing your User Set-up ...55 Changing a password ...56 Changing paths...56 Defining a muscle list...57

Network Configuration ...58 Setting up a shared network database...59 Setting up configuration information ...59 Setting up users to share data ...59 Sharing existing data on a local drive ...60

5: Configuring protocols... 61 Introduction ...61 On-line configuration...61 Change trace sensitivity ...62 Change trace duration ...62

Protocol Configuration Wizard...63 Entering the Protocol Configuration Wizard...63 Editing an existing protocol ...64 Creating a new protocol ...64 Acquisition set-up ...65 Electrical Stimulator Set-up ...69 Protocol Table set-up ...70 Channel Mapping and Trace Depth set-up...71

6: The tests ... 73 Using the tests ...73 The typical test procedure ...74

Selecting the test ...75 Selecting a protocol ...75 Motor NCS Test ...76 Clinical Overview ...76 Running the Motor NCS test...76

Sensory NCS Test ...83 Clinical Overview ...83 Running the Sensory NCS test ...83 iv

INTRODUCTION

F-Wave Test ...89 Clinical Overview ...89 Running the F-Wave test...89

H-Reflex Test ...94 Clinical Overview ...94 Running the H-Reflex test...94

Needle EMG Test...97 Clinical Overview ...97 Running the Needle EMG test...97

Repetitive Nerve Stimulation Test ...104 Clinical Overview ...104 Running the Repetitive Nerve Stim test ...104

Blink Reflex Test ...110 Clinical Overview ...110 Running the Blink Reflex test ...110

Sympathetic Skin Response Test ...114 Running the Sympathetic Skin Response Test ...114

Interference Pattern Analysis Test...115 Clinical Overview ...115 Running the Interference Pattern Analysis test ...117

Multi-MUP Analysis Test ...120 Clinical Overview ...120 Running the Multi-MUP Analysis Test...122

Single Fibre Jitter Test ...126 Clinical Overview ...126 Running the SFJ Test (Volitional)...126 Running the SFJ Test (Stimulated) ...131

Fibre Density Analysis Test...137 Clinical Overview ...137 Running the Fibre Density Analysis Test...137

Macro EMG Test ...140 Clinical Overview ...140 Running the Macro EMG Test ...140

Trace analysis and display...144 Selecting traces...144 Moving traces...145 Superimposing traces ...145 Automatic marker placement ...145 Manual marking of traces...146 Change trace sensitivity...147 Change trace duration...147 Compare ...147 v

SYNERGY USER MANUAL

Trace arithmetic ...148 Split sensitivity...149 Using the full trace area ...149 Trace area setup ...149

Configuring and displaying results...151 Results Table...151 Result Mode ...151 Reference Values ...152 Configuring the Results Table ...153 Setting up custom results ...155 Temperature probe ...156 Displaying the full Results Screen ...156

Appendix A Installation & Maintenance ... 1 Installation...1 WARNING ...1 Checks...1 Environment...1 Power supply connections...2 Connecting the equipment...7 Cables...7 Connecting other electrical equipment...8 Switching on ...19 Switching off...19 Special instructions for use ...20 Electrical stimulating electrodes ...21 Stimulators ...22 Footswitch...23 Printer...23

Maintenance ...24 After-sales service support...24 Maintenance of the instrument...24 Cleaning ...24

Electrodes...25 Electrode kit supplied by the Synergy manufacturer ...25

Appendix B Interface Connections... 1 Signal Cable ...1 Connectors on Notebook PC and PC Tower ...1 Connectors on PIU ...1

Appendix C Technical Specifications... 1 Amplifiers and Filters ...1 Data Acquisition and Display ...1 Electrical Stimulator ...1 Dimensions (Patient Interface Unit)...2 Power Requirements ...2 vi

INTRODUCTION

ISO800 Mains Isolating Transformer...2 Safety Standards...3 EMC Standard...3 Quality Standards ...3

Appendix D Assembling the Notebook Stand ... 1 Assembly instructions ...1

Appendix E Cable management for the Tower... 1

vii

SYNERGY USER MANUAL

Using this Manual This user manual is intended to be read by anyone who is to use Synergy Notebook, Synergy Tower or Synergy Suite. Immediately after this section are notes on safety considerations and a list of the symbols used in Synergy. Then the manual is structured in chapters as follows: Chapter 1 Overview of the system illustrates and describes the Synergy and its parts; explains briefly how basically to use the system; outlines the basic features of the system. Chapter 2 Handling patient information describes how to enter, save and retrieve patient details, review patient results and reports and search for patient information, and how to transfer patient information between the Synergy systems Chapter 3 Generating reports describes how to obtain reports on-line, recall reports and print them, and customising the report layout. Chapter 4 Configuring the system describes how to configure such elements as database paths, user set-up and muscle lists. Some information in this chapter is for administrators only. Chapter 5 Configuring protocols describes how to configure on-line, and how to use the Protocol Configuration Wizard. Chapter 6 The tests describes all the tests in detail and how to run them; selecting and marking traces; configuring and displaying results. The Appendices cover installation and maintenance of the system; interface connections and full technical specification of the system.

viii

INTRODUCTION

Safety and symbols Safety considerations Synergy complies with EN 60601-1, the European standard for safety for medical electrical equipment: For type of protection against electrical shock: Class 1 For degree of protection against electrical shock: Type BF For degree of protection against harmful ingress of liquid: Ordinary (no protection) For the mode of operation: Continuous For the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide: Not suitable Synergy also complies with: UL2601-1, the American standard for safety for medical electrical equipment CAN/CSA22.2 No.601.1, the Canadian standard for safety for medical electrical equipment EN60601-1-1, the European standard for safety for medical electrical systems EN 60601-1-2, the European standard for electromagnetic compatibility requirements for medical electrical equipment EN60601-2-40, the European standard specifying particular safety requirements for electromyographs and evoked response equipment _____________________ Synergy bears the CE Mark - to show compliance with the European Medical Device Directive (93/42/EEC). Synergy is designed and manufactured under approved Quality Management Systems: EN 29001/ISO 9001:1994, Quality System Standard

ix

SYNERGY USER MANUAL

EN 46001:1994, Quality System Standard application to manufacture medical devices

Caution and warnings 1. U.S. Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner. 2. It should be noted that it is the responsibility of the user to ensure that conformance to the Type BF patient isolation requirements of EN60601-1, UL2601-1 and CAN/CSA22.2 No.601.1 is maintained when patient connected equipment or accessories not supplied by Oxford Instruments Medical Ltd are used with Oxford Instruments Medical Ltd equipment. 3. If any mains powered equipment, for example printers, video monitors or other medical equipment, is to be connected to Synergy to form a medical electrical system then the requirements of standard EN60601-1-1 (Medical Electrical Equipment, Part 1. General requirements for safety, Section 1.1 Collateral standard: Safety requirements for medical electrical systems) must be complied with to ensure patient and operator safety is maintained. 4. There are no user serviceable parts inside the instrument. Only appropriately trained and qualified personnel should adjust, maintain or repair the instrument when it is connected to the electricity supply. The instrument must be disconnected from the electricity supply first, before any cover is removed.

Responsibility of the manufacturer Oxford Instruments Medical Ltd and our distributors consider themselves responsible for the effects on safety, reliability and performance of the equipment only if: • assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorised by them • the electrical installation of the relevant room complies with the appropriate requirements • the equipment is used in accordance with the instructions for use Full compliance of this product cannot be ensured unless all components (leads etc.) are provided by Oxford Instruments Medical Limited.

x

INTRODUCTION

Disposal of equipment When the equipment comes to the end of its operating life, it should be disposed of in accordance with local waste disposal regulations. Advice on this can usually be obtained from the local waste regulation authority which is typically to be found within the local government office.

Electrical interference suppression These notes are intended as a guide to the location and suppression of electrical interference. This may affect apparatus involving the detection and analysis of signals of a few microvolts in the frequency range DC to 20kHz, such as for Electroencephalographs (EEG) or Electromyographs (EMG) and Evoked Potential (EP) Recording Systems. 1. 50Hz/60Hz magnetic field from power transformers, induction motors etc. The only practical protection from this type of interference is the avoidance of loops in the pick-up circuits of the EEG or EMG/EP, since the magnitude of the interfering voltages is directly proportional to the area enclosed by any such loop. 2. Magnetic field from staff location systems using inductive loops This type of interference is of an intermittent character and may be serious where the inductive loop runs alongside the wall of the examination room and where the transmitted frequencies fall within the pass band of the EEG or EMG/EP. Most modern staff location systems now use frequencies above 20kHz and should, therefore, cause minimum interference unless the loop is very close to the EEG or EMG/EP. 3. 50Hz/60Hz electrostatic field from unshielded conductors, lamps etc. This type of interference is possibly the simplest to locate and correct. Any conductor of supply frequency not covered by an earthed metal screen is a potential source of interference. Obvious sources are flexible cables to desk lamps and X-ray viewing boxes, unshielded fluorescent tubes and filament lamps. It is important that all encasing metalwork of electrical equipment be securely bonded electrically to the local circuit earth.

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SYNERGY USER MANUAL

4. HF interference from short-wave diathermy, radio ambulances, television and sound broadcasting This class of interference is the most difficult to track down to its source and by far the most difficult to eliminate. Short-wave diathermy is easily the most frequent source of HF interference, particularly in or near a physical medicine department or operating theatre. The interference may reach the EEG or EMG/EP via a number of paths falling into two main categories: (1) Conducted and (2) Radiated. Conducted HF interference is found on the mains supply. This kind of interference on modern equipment is eliminated by efficient mains filtering. Radiated interference is transmitted through the air and emitted either from poorly screened electrical equipment or other sources such as radio and TV transmitters and hospital paging systems. In severe cases of this kind, a screened enclosure is essential.

Sources of artefact The following list shows some of the more usual causes of corruption of the signal that Synergy has to process. Audio feedback Broken electrode lead wire including ground electrode wire Diathermy Dirty electrodes Electrode lead wire movement Electronic dimmers Excessive low or high power-line voltage Fluorescent lights Ignition noise Incorrect electrode connection to apparatus Intermittent power-line load Microphony Multiple grounds in the screened room Pick-up from monitor screens Poor apparatus ground Poor ground electrode location Poorly shielded printers Power cables near patient not unplugged at wall socket Radio and TV Ungrounded observers Ungrounded wheelchair or table xii

INTRODUCTION

Symbols and their definition Note: Some symbols are used only on Synergy Tower or only on Synergy Notebook. Some symbols will not appear on your unit if they are replaced by text in your own language.

Information

! ! "

Refer to the appropriate pages of this manual for information

Warning that the unit contains high voltage parts inside Preamplifier

#

Stimulus

$

Stimulus duration

#/s

Stimulus repetition rate

%

Audio signal

&

Display Sensitivity

'

Sweep Duration

Fn

Function

xiii

SYNERGY USER MANUAL

+ -

Trigger - falling edge

"

Equipotential earth terminal

#

Isolating transformer

M(

Next store

M+

Acquire

"

Double arrow head – continuous (Acquire)

#

Single arrow head – momentary (Acquire)

M-

Erase stores

)

Direct current (dc)

*+

Alternating current (ac)

$

Risk of explosion – do not use in the presence of inflammable anaesthetics

"

Stimulus duration increase/decrease

" xiv

Trigger - rising edge

Rotate clockwise to increase

INTRODUCTION

Connections

,+

The Type BF symbol is placed adjacent to connectors used for Type BF floating patient applied parts

-

Input

.

Output

$

External printer interface

%

Footswitch

&/!

'

External keyboard / Mouse

Patient ground

(

Stimulus Probe

)

Universal Serial Bus

*

Communications Port

xv

SYNERGY USER MANUAL

+ ,

xvi

Temperature Probe

External Monitor

INTRODUCTION

Switches

/

OFF (Mains supply)

0

ON (Mains supply)

-

Amplifier OFF

.

Amplifier ON

Warning Symbols The symbol

! with a letter adjacent to it is used to refer to

one of the specific warnings listed below. These symbols will not appear on your unit if the warning is written in full in your own language.

" " " "

CAUTION: TO REDUCE THE RISK OF ELECTRIC SHOCK DO NOT REMOVE COVER. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL.

BEFORE CONNECTING REFER TO SYNERGY USER MANUAL. CAUTION: DO NOT OBSTRUCT COOLING VENTS. NO USER SERVICEABLE PARTS INSIDE.

xvii