Digitimer DS7A, Operator'S Manual

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...