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Operator's Manual

DS7A - Constant Current Stimulator

D185-FS1

This medical grade foot switch is sealed to IP68 so as to meet all the requirements of EN 60601
(IEC 60601), including for use within operating theatres.

The lead is fitted with a mono 3.5 mm jack plug. A 3.5 mm to ¼” jack plug adapter to allow the foot switch
to be plugged into the

DS7A

is supplied.

Note that it is the pressing of the foot switch which initiates a stimulus to the patient. The releasing of the
foot switch or continued pressing of it does not produce any extra stimuli.

The foot switch should only be inserted into the

DS7A

“Foot Switch” socket (rear panel) when the DS7A

Output Enable switch is in the Disabled (down) position.

Digitimer Ltd.

39 of 58

Copyright © 2014

File Ref: N:\Docs\Company\Manuals\DS7A\Issue-14\DS7A-iss14.odt

Last Revised: February 1, 2017

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Содержание DS7A

Страница 1: ...7AH OPERATOR S MANUAL 0120 The DS7A DS7AH has been Listed for human use in Europe USA Canada and other Countries Caution Federal law restricts this device to sale by or on the order of a physician Dig...

Страница 2: ...ake time out to register your new product Details are included in the General Information Chapter You can even do it online at www digitimer com register Digitimer Ltd 2 of 58 Copyright 2014 File Ref...

Страница 3: ...S7A DS7AH Constant Current Stimulator NOTE Where DS7A is written is this manual details apply to the DS7A and DS7AH unless noted otherwise Digitimer Ltd 3 of 58 Copyright 2014 File Ref N Docs Company...

Страница 4: ...his page is left intentionally blank to provide an insertion place of any changes subsequent to the printing of this document Digitimer Ltd 4 of 58 Copyright 2014 File Ref N Docs Company Manuals DS7A...

Страница 5: ...Issue 14 DS7A iss14 odt Last Revised February 1 2017 WARNING For Patient and Operator safety this manual should be fully read and understood before use of this product CAUTION Please note that where P...

Страница 6: ...uderdale FL 33301 Tel 1 954 713 8017 Fax 1 954 523 1911 E mail MEPsllc aol com 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 8...

Страница 7: ...___________________________________________ ________________________________________________________________________________ ___________________________________________________________________________...

Страница 8: ...for announcements of new 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...

Страница 9: ...5 Precautions Warnings 15 Product Intended Usage 18 Indications for Use 18 Explanation of Symbols Used on DS7A 19 Front Panel Controls 21 Notes on Front Panel Controls 22 Rear Panel Controls 23 Insert...

Страница 10: ...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 Sym...

Страница 11: ...Appendix 5 Guidance Declarations on Electromagnetic Compatibility 52 Appendix 6 Guidance on system integration 56 Warranty Information 57 Limited Warranty 57 Obtaining Warranty Service 57 Product chan...

Страница 12: ...ator s Manual DS7A Constant Current Stimulator EU Declaration of Conformity Digitimer Ltd 12 of 58 Copyright 2014 File Ref N Docs Company Manuals DS7A Issue 14 DS7A iss14 odt Last Revised February 1 2...

Страница 13: ...perator s Manual DS7A Constant Current Stimulator FDA Indications for Use Digitimer Ltd 13 of 58 Copyright 2014 File Ref N Docs Company Manuals DS7A Issue 14 DS7A iss14 odt Last Revised February 1 201...

Страница 14: ...vely a foot switch may be connected to a socket on the rear panel or the front panel push button pressed A TTL compatible Trigger output is provided at a BNC socket at the rear panel this can be facto...

Страница 15: ...mulator 1 x Power Cord 110 V or 230 V type depending on your location 1 x DS7A Stimulator Operator s Manual 1 x Safety Certificate for the unit If any of these are missing please contact your Distribu...

Страница 16: ...lectronic Implants Understand that this unit may not be appropriate for use on patients with cardiac pacemakers or electronic implants j Do NOT use transthoracically Only use this Stimulator on one li...

Страница 17: ...o measure the stimulus current by inserting a resistor into one stimulating lead and using an oscilloscope to measure the voltage drop across the resistor are likely to violate the rule of not connect...

Страница 18: ...than reasonable standards for use as a medical product As stated in the Digitimer Limited Warranty Statement supplied with each product Digitimer Limited Expressly disclaims all warranties to buyer e...

Страница 19: ...A Vmax Output Stimulus Adjustment for maximum Voltage of stimulus Consult operator documentation this manual before use of this equipment s Output Stimulus Stimulus in s Output pulses are set to posit...

Страница 20: ...e supervision of Notified Body 0120 SGS UK Ltd 0120 Trigger Input signal input connector Positive going pulse required Output signal output connector Active high square wave pulse produced Foot switch...

Страница 21: ...e DS7A this gives either an output range of 0 10 mA as indicated in the window of the Current Amplitude Control or 0 100 mA by multiplying Current Amplitude Control display by a factor of ten For the...

Страница 22: ...ontrols 1 With the Output Enable switch 9 in the ON upward position i The FAULT lamp 12 will be on at POWER ON ii The FAULT lamp 12 will come on if a Fault is detected iii The FAULT lamp 12 will NOT g...

Страница 23: ...xtra Earthing terminal to the PROTECTIVE EARTH CONDUCTOR that is the third wire in the mains cable It is fitted to allow an earth reference for the unit and bonding point for connection to a POTENTIAL...

Страница 24: ...e same sockets This photograph shows the correct orientation Red Plug to Red Socket To get to this point very little force is required This photograph shows the connector partially inserted At this po...

Страница 25: ...control operates correctly in the normal reverse and alternating polarity modes If the Triggering is set for the DS7A to trigger the EMG system check that when the Trigger button is pressed the EMG sy...

Страница 26: ...socket going negative with respect to the black output socket This mode is selected by placing the toggle switch into the right position Alternating Polarity Alternating is defined as Normal followed...

Страница 27: ...some of the pulse duration because the Voltage selected was too low for the impedance of the patient electrode circuit This can indicate one of two things Firstly that the electrode is not in proper...

Страница 28: ...frequency at which the unit can be triggered for a given output current and pulse duration can be calculated using the following equation Freq 5 000 000 PW x Imax where Freq is the trigger frequency...

Страница 29: ...t Stimulator GRAPHS OF MAXIMUM REPETITION RATES NOTE Frequencies above 1000 Hz are not permitted with the DS7A Digitimer Ltd 29 of 58 Copyright 2014 File Ref N Docs Company Manuals DS7A Issue 14 DS7A...

Страница 30: ...oes positive with reference to black socket Trigger The Maximum trigger rate is 1 000 pps 1 kHz INPUT Electrical via Rear Panel BNC socket Triggers Logic signal 3 to 15V ve edge TTL compatible ve edge...

Страница 31: ...00 240 V mains T 125 mA L 5 x 20 mm 250 V Internal Fuses Note these should NOT be changed by non qualified persons Fuse Reference F3 and F4 TE5 400 mA 125 V Antisurge Dimensions Size 255 x 100 x 225 m...

Страница 32: ...the ulnar nerve on the patients wrist through to large self adhesive electrodes needed to obtain the low electrode impedance necessary when stimulating large muscles such as the quadriceps Please cont...

Страница 33: ...hat if the lead is pulled the ground wire cannot come into contact with the line or neutral pins This Instrument MUST be Earthed Grounded In the USA reliable grounding can only be achieved when the eq...

Страница 34: ...triggers from a negative going from a positive voltage greater that 3V to zero volts input The minimum voltage that is applied to this socket is 0 5V The maximum voltage that is applied to this socke...

Страница 35: ...nnection to patient Cathode Output signal output connector Note Only connect to other Medical Equipment Type BF applied part Digitimer have declared that this equipment complies with the Medical Devic...

Страница 36: ...m DIN 42 802 1 style TouchProof sockets for both connections for those who wish to use protocols with linked cathodes and or anodes The moulded twin shrouded 4 mm connector not shown should be inserte...

Страница 37: ...2 1 style TouchProof sockets that are colour coded to the original sockets The moulded twin shrouded 4 mm connector shown above centre should be inserted into the pair of DS7A Stimulus Output sockets...

Страница 38: ...d when necessary Please refer to the Connection of the DS7A to an EMG System section of this manual for more details of the cable required and connection details D185 TC1 Trigger Cable BNC 3 5 mm 1 5...

Страница 39: ...tch to be plugged into the DS7A is supplied Note that it is the pressing of the foot switch which initiates a stimulus to the patient The releasing of the foot switch or continued pressing of it does...

Страница 40: ...is done by the trigger connection cable Modes There are two basic modes of trigger synchronisation 1 DS7A triggers the EMG system Uses the DS7A Trigger Out socket to transmit the trigger signal to the...

Страница 41: ...enable different levels of Artefact rejection Precise methods will vary with manufacturer and model Depending on the particular set up used the DS7A can often produce large amplitude stimulus artefac...

Страница 42: ...pulse required Negative going pulse required Foot switch connector Note Only connect to other Medical Equipment Description of socket function TRIGGER OUT socket provides a trigger output pulse whene...

Страница 43: ...e signal 1 ms duration for recorder synchronisation 100 s and or active low by internal change Trigger pulse to output stimulus relationship An external Trigger In or front panel button or foot switch...

Страница 44: ...man pharyngoesophageal motor excitability induced by swallowing pharyngeal stimulation and anesthesia Am J Physiol Gastrointest Liver Physiol 285 137 144 10 Mario Ubaldo Manto Massimo Pandolfo and Joh...

Страница 45: ...l 91 1341 1349 25 Burke D Bartley K Woodforth I J Yakoubi A Stephen J P H 2000 The effects of a volatile anaesthetic on the excitability of human corticospinal axons Brain 123 992 1000 26 Holloway V G...

Страница 46: ...moved Trigger Out is 1 ms max Rep is 1000 Hz 11 Front Rear panels labelling changed to include more symbols and conformance with the MDD requirements Trigger LED now amber not Green 12 Internal modifi...

Страница 47: ...nged the two internal fuse holders from clips which are prone to weakening over time to a board mounted type This reduces the risk of either fuse going open circuit which can result in overloading and...

Страница 48: ...AH has an increased stimulus current pulse output providing maximum currents of 100 mA on the x1 range and 1000 mA on the x10 range compared to 10 mA and 100 mA for the standard DS7A The current outpu...

Страница 49: ...lus output potential generated across the 100R resistor should be 10 volts peak 1 ms wide Check that the amber Trigger indicator is turned on 2 Now close SW1 and check that potential across 100R resis...

Страница 50: ...t not replace the training and experience required for testing medical electrical equipment Test Procedure Before commencing the test procedure it is important to fully understand the operation of the...

Страница 51: ...ition and single fault condition may be taken with the DS7A connected as described Insulation Resistance Insulation resistance may be measured using test voltages of up to 350V Functional Test Refer t...

Страница 52: ...DS7A uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The...

Страница 53: ...2 kV Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip...

Страница 54: ...te survey a should be less than compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher...

Страница 55: ...ransmitter m 150 kHz to 80 MHz d 3 5 3 P 80 MHz to 800 MHz d 3 5 3 P 800 MHz to 2 5 GHz d 7 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 12 1 12 2 33 10 2 88 2 88 5 76 100 11 67 11 67 23 33 For tran...

Страница 56: ...involved studies like those above there are two methods by which this hazard can be eliminated 1 Power the non medical devices via a separation or isolation transformer This removes the leakage curren...

Страница 57: ...fications or alterations have been made to the Product This warranty applies to software products only to the extent of maintenance release software to correct improper operation of the Product Softwa...

Страница 58: ...347 Int 44 1707 328347 Fax UK 01707 373153 Int 44 1707 373153 E mail sales digitimer com or technical digitimer com Website www digitimer com Issue 14 C N 2219 Date 30 04 14 File Ref N Docs Company Ma...

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