Digitimer DS7A Manuale utente
Digitimer
Constant Current Stimulator
DS7A (including DS7AH)
OPERATOR’S MAN AL
0120
The DS7A/DS7AH has been Listed for human use
in Europe, USA, Canada and other Countries.
Caution: Federal la restricts this device to sale by or on the order of a physician.
‘Digitimer’ is a registered Trade Mark of Digitimer Limited
Operator's Manual DS7A - Constant Current Stimulator
Product Registration
Please take time out to register your ne product.
Details are included in the General Information Chapter
You can even do it online at:-
.digitimer.com/register
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Operator's Manual DS7A - Constant Current Stimulator
The Digitimer DS7A & DS7AH Constant Current Stimulator
NOTE: Where “DS7A” is ritten is this manual, details apply to the DS7A and DS7AH
unless noted other ise.
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Operator's Manual DS7A - Constant Current Stimulator
This page is left intentionally blank to provide an insertion place of any changes subsequent to the printing
of this document.
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Operator's Manual DS7A - Constant Current Stimulator
Warning & Caution
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WARNING
For Patient and Operator safety, this manual
should be fully read and understood before use
of this product.
CA TION
Please note that here
“Percutaneous Stimulation”
is referred to in this document, it means
“Electrical Stimulation Through the Skin”
and NOT the use of Needle electrodes.
Operator's Manual DS7A - Constant Current Stimulator
Contact Addresses
Manufactured by:
Digitimer Limited
37 Hyde ay
Wel yn Garden City
Hertfordshire
AL7 3BE
UK
Telephone:- (UK) 01707 328347 (Int.) +44 1707 328347
Fax:- (UK) 01707 373153 (Int.) +44 1707 373153
E-mail:- [email protected] or
Website:- .digitimer.com
Main Representatives:
SA MEPs, LLC
One East Bro ard Blvd.
Suite 700
Fort Lauderdale, FL 33301
Tel: +1 954 713-8017
Fax: +1 954 523-1911
E-mail: [email protected]
Japan Miyuki Giken Co. Ltd
Hongo Daiya Building 6F
18-14, 3-Chome, Hongo
Bunkyo-ku
Tokyo 113-0033
Tel : +81 (0)3-3818-8631
Fax : +81 (0)3-3818-8632
E-mail: [email protected]
Germany Helmut Wehking
Vertrieb MedicalProducts
Neuberg 1-b
D-65193 Wiesbaden
Tel: +49 (0)611 185 1944
Fax: +49 (0)611 185 1946
E-mail: helmut ehking@ ehking-med.de
Please contact Digitimer for Representatives in other countries.
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Operator's Manual DS7A - Constant Current Stimulator
Purchase Information
A record of salient information, on this page, ill aid the Operator should this information become necessary
in the future.
Date of Purchase: ____________________________________________________________
Dealer: ____________________________________________________________
Dealers Tel. Number: ____________________________________________________________
Dealers Fax Number: ____________________________________________________________
Dealers e-mail address: ____________________________________________________________
Contact name at Dealer:____________________________________________________________
Serial Number of Unit: ____________________________________________________________
Other Notes: ____________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
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Operator's Manual DS7A - Constant Current Stimulator
Product Registration
Why Register your purchase?
Digitimer Limited periodically offers enhancements and updates to our products. Without product
registration, users of our products may miss out on announcements of important enhancements to the
products that they are using.
Digitimer Limited does not make our customer list available to anyone else. Any information that you
provide to us is strictly confidential.
How to Register your purchase
Product registration can be accomplished in t o ays. You may fill out and mail in the product
registration/ arranty card supplied ith each Digitimer Limited product. You may also register on-line at
our www.digitimer.com/register eb page.
Product announcement mailing list
Digitimer Limited has e-mailing lists hich e use as our primary outlet for announcements of ne products,
product enhancements and product updates. We strongly recommend that all users of our products sign up
for the list that is most appropriate to their area of interest. E-mail is kept to a minimum and list
membership is kept in the strictest confidence. Only Digitimer Limited can send mail to members of our e-
mailing lists.
You may join the DS7A mailing list through our www.digitimer.com/register eb page.
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For a speedy response to all your questions no and in the future, please take time out to
register your ne DS7A Stimulator at www.digitimer.com/register no !
Product registration permits us to quickly advise you of any safety matters or ne product
information.
A point of contact for all questions regarding the DS7A is www.digitimer.com/support.
The site’s contents are no gro ing rapidly, so please bookmark it so that you visit it
regularly to check out the ne items.
Operator's Manual DS7A - Constant Current Stimulator
Table of Contents
Warning & Caution...............................................................................................5
Contact Addresses................................................................................................6
Purchase Information..........................................................................................7
Product Registration............................................................................................8
Why Register your purchase?..............................................................................8
Ho to Register your purchase...........................................................................8
Product announcement mailing list......................................................................8
E Declaration of Conformity............................................................................12
FDA – Indications for se..................................................................................13
Equipment Description.......................................................................................14
Regulatory Statements......................................................................................14
EN 60601-1:2006 + A1:2013 Classifications.......................................................14
Environmental..................................................................................................14
Cleaning, Maintenance & Servicing...................................................................14
npacking your DS7A Stimulator......................................................................15
Accessories.........................................................................................................15
Precautions & Warnings....................................................................................15
Product Intended sage....................................................................................18
Indications for se.............................................................................................18
Explanation of Symbols sed on DS7A..............................................................19
Front Panel Controls..........................................................................................21
Notes on Front Panel Controls.................................................................22
Rear Panel Controls...........................................................................................23
Insertion of DS7A Stimulus Output Connector..................................................24
Installation & Initial Check................................................................................25
Stimulus Control................................................................................................26
'Pulse Duration' control.....................................................................................26
'Pulse Polarity' control.......................................................................................26
'Normal' Polarity.....................................................................................26
'Reverse' Polarity....................................................................................26
'Alternating' Polarity................................................................................26
“Too-fast” Warning and Cut-out...............................................................26
'Current max.' control and 'x1/x10' Range s itch...............................................26
'Volts max.' control...........................................................................................27
'Out of Compliance' indicator............................................................................27
Maximum Stimulus Repetition Rates................................................................28
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Operator's Manual DS7A - Constant Current Stimulator
Trigger Out Pulse Duration................................................................................28
Specifications.....................................................................................................30
Stimulus Output......................................................................................30
Trigger...................................................................................................30
Indicators...............................................................................................30
External Fuses........................................................................................31
Internal Fuses........................................................................................31
Dimensions............................................................................................31
Temperature..........................................................................................31
Other.....................................................................................................31
Stimulating Electrodes.......................................................................................32
Mains Connection...............................................................................................33
Mains Plug connections...........................................................................33
Mains Plug fuse......................................................................................33
Mains Voltage Selector............................................................................33
Trigger Polarity..................................................................................................34
Input trigger...........................................................................................34
Output trigger........................................................................................34
Explanation of Symbols sed on Accessories....................................................35
D185-HB1...........................................................................................................36
D185-HB4...........................................................................................................37
D185-TCx - Trigger Cables.................................................................................38
D185-FS1...........................................................................................................39
Connection of DS7A to an EMG System.............................................................40
Introduction.....................................................................................................40
Modes.............................................................................................................40
DS7A - Trigger-Out.................................................................................40
DS7A - Trigger-In...................................................................................40
Setting up the EMG system...............................................................................41
Artefact Rejection.............................................................................................41
Making Trigger Connections to the DS7A...........................................................42
Symbols used in connection ith the Trigger.....................................................42
Description of socket function...........................................................................42
Electrical characteristics of Triggers...................................................................43
Trigger pulse to output stimulus relationship......................................................43
Bibliography.......................................................................................................44
Appendix 1 .. DS7A Modification Record Status................................................46
Ne Instruments.............................................................................................46
Units that have been modified after first delivery...............................................46
The Modifications made....................................................................................46
Appendix 2 .. DS7AH - High Output Current......................................................48
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