Technical Manual
Contents
1. oT Jot Tok Jel tel C61C48 7 fooi S20 TPI o ICS S Wmo ooo ofofo SV3 C42 C43 All Dimensions in mm Mechanical drawing top view of the module 1 1 Overview The scope of this document is the description and specification of Medlab s three lead ECG board EG01010 It should help anybody who is familiar with both programming and basic electronics to select the proper hardware and software version for his application as well as to help him integrate the board into his own electronic system The EG01010 measures one of three channels of ECG using a three lead cable The isolated patient ground must not be connected to the mains ground The EG01010 has full patient isolation on the board that means that the input voltage of 5 volts has no galvanic contact to the patient Furthermore the module is defibrillation protected The isolation gap can be easily seen on the board it is the area that is bridged only by the transformer 76250 and the couplers ADUM2402 No connections to2. Description of connectors and areas of the module 1 1 Physical Units of Transmitted Data Scaling of ECGs is done normally in the unit cm mV for the Y axis and in mm sec for the X axis Respiration rate is transmitted in rpm respirations per minute Pulse rate is transmitted in bpm beats per minute Transmission speed for the wave is indicated in Hz sec 1 ECG amplitudes are normally indicated in cm mV Since this is depending directly on the resolution of the screen the user is working with the transmitted samples are not directly scaled in this unit but fall into the range of 0 OxF7 8 Bit samples OxF8 to OxFF reserved for commands It is within the responsibility of the user to scale the transmitted samples in a way that the waves displayed onto his screen fit to the usual scales used in medicine 0 5 1 2 and 4 cm mV The amplification of the module in the different amplification stages is Stage 1 Stage 2 Stage 3 1mv 32 1mV 64 1mV 128 Normal values for the trace speed are 12 5 mm sec 25 mm sec and 50 mm sec 5 Version 1 02 22 04 2013 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Technical Data Specifications Mechanical data Maximum height With respiration option Attachment Weight Operating voltage Power consumption Input Patient Isolation Amplification Data transmission Filtering Amplifier frequency range Pulse detection R
3. 27 clause 50 102 13 Without over undershoot a For single ventricular only pacemaker pulses alone with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate as zero bpm Asystole b For single ventricular only pacemaker pulses with normally paced QRS T with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of the QRS T rhythm 60 bpm for the specified test waveform c For single ventricular only pacemaker pulses with ineffectively paced QRS pattern with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of the underlying QRS T rhythm 30 bpm d For atrial ventricular pacemaker pulses alone with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of zero bpm Asystole e For atrial ventricular pacemaker pulses with normally paced QRS T with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of the QRS T rhythm 60 bpm f For atrial ventricular pacemaker pulses with ineffectively paced QRS pattern with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of the underlying QRS T rhythm 30 bpm With over undershoot a For single ventricular only pacemaker pulses alo
4. EG0 1010 ia ranra wrist A For easy integration of the module into medical systems a test software has been made available The EG01010 can be connected directly to a PC the received data is shown on the screen To run the program connect the EG01010 board to the serial port of a PC If the PC has no serial port please use a USB to RS232 adapter and install the driver of this adapter first and make sure to create a virtual serial port Connect the power input to a 5 volts DC source Then start the program on your PC and select the serial port number in the Port menu Commands can be sent to the board by pressing the command buttons in the application Since the same software can be used for the one channel EG01000 and the three channel EG01010 board some buttons have no function when used with the EG01010 The software is available free of charge on www medlab eu on the page describing the EG01010 The software is written in Visual Basic 6 and the source code is also included in the download package Version1 02 22 04 2013 14 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Regulatory Considerations The device that has been described in this document is not a final medical product That means that it cannot be used as a standalone unit to use it on patients Therefore theEG01010 has not been and also cannot be CE marked The customer has to undertake the procedure of CE marking the final product that c
5. FA 0x78 OxF8 0x25 0x25 0x26 Time 11 Version 1 02 22 04 2013 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Commands accepted by the Module All commands have a one or two byte structure They are also sent to the module with 9600 baud The commands are sent in ASCII format Basic Bandwidth of ECG amplifier Diagnostic or Monitoring mode F Parameter 0 or 1 0 bandwidth of the amplifier DC 80 Hz Diagnosticmode bear in mind mains filter setting 1 bandwidth of the amplifier 0 67 40 Hz Monitoringmode resetvalue extra strong filter lower edge frequency 2 Hz Transmission frequency of the waveform packet o Parameter 0 1 2 0x53 0x31 for example for S1 0 send waveform packets 300 times per second 1 send waveform packets 100 times per second reset value 2 Send waveform packets 50 times per second Amplification of the waveforms A Parameter 0 1 2 or 3 0x41 0x31 for example for A1 0 Amplification stage 1 lowest amplification should be scaled to 0 5 cm mV 1 Amplification stage 2 2 Amplification stage 3 highest amplification should be scaled to 2 cm mV Each amplification stage has double the sensitivity of the previous stage Channel selection 1 wave channel can be selected G Parameter 0 1 or 2 for Einthoven Ill Il or selection Filtering of the waveforms for 50 and 60 Hz li
6. OV 5V levels which saves parts on the customers side of the data stream Connector JP1 is compatible with the interface connector on Medlab s EG05000 five channel ECG OEM board Therefore test cables that have been built for this board can also be used for the EG01010 board The EG01010 sends a continuous data stream and receives commands Commands are one byte characters some of them have an additional parameter others just toggle an internal switch in the EG01010 module The neutral line of the ECG always lies at 128 the module transmits unsigned byte data While a lead off condition is active a pulse value of 0 and a neutral line of 128 is transmitted The module powers up with amplification set to level O and speed set to level 1 which means lowest amplification stage and transmission of 100 sample points per second Simulation mode is off at power up the notch filter is set to 50 Hz and monitoring mode is selected For details please see the protocol description on the following pages Version1 02 22 04 2013 10 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Serial Transmission Protocol All data is transmitted at 9600 baud 8 bits 1 stop bit no parity Each time a pulse is detected by the board s internal algorithm a block with a new averaged pulse rate is transmitted The pulse detector is of high quality and the point in time where the pulse marker OxFA is transmitted can be used for triggering appl
7. active rectangular signal with a pulse width of 33 ms Delay to the R wave can be adjusted by a command Header for patient cable connection SV1 NOOR N Unused SHIELD LL IN RA IN LA IN SHIELD Unused Three Lead Patient Cable g 3 lor Il or Ill It is very important to connect the black clamp to the left leg or hip not to the right leg or hip of the patient If you connect it to the wrong leg there is one channel that shows no ECG at all the Il channel because the board tries to sense the voltage between right arm and right leg in this case ECG cable connection Remark For respiration measurement optional respiration board needed electrodes should be attached to chest and hip not arm and leg Version 1 02 22 04 2013 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Technical Description for TRF IEC 60601 2 27 When preparing a test report form TRF for proof of compliance of the user s medical product to IEC60601 2 27 2005 the following remarks technical data will be helpful or needed Input Impedance gt 10MOhm Common mode rejection ratio gt 90 dB at 50 Hz or 60 Hz Input Dynamic Range 5 mV AC 300 mV DC Defibrillator Discharge Recovery lt 10 sec per IEC 601 2 27 lt 10 sec per AAMI EC 13 1992 Leads off sensing current Applied currents less than 150 nA The following information references particular sections of IEC 601 2 27 Respiration option
8. al Section 6 8 2 bb 1 Applied currents less than 80 pA 90 kHz square Tall T wave rejection Section 6 8 2 bb 2 T wave of 1 2 mV amplitude will not affect heart rate determination Heart rate averaging Section 6 8 2 bb 3 TBD Response to irregular rhythm Section 6 8 2 bb 4 A1 Ventricular bigeminy the EG01010 counts both large and small QRS complexes to display a rate of 80 bpm A2 Slow alternating ventricular bigeminy the EG01010 counts both large and small QRS complexes to display a rate of 60 bpm A3 Rapid alternating ventricular bigeminy the EG01010 counts all QRS complexes to display a rate of 120 bpm A4 Bi directional systoles the EG01010 counts all QRS complexes to display a rate of 90 bpm Heart rate meter response time Section 6 8 2 bb 5 a Change from 80 to 120 BPM 4 sec b Change from 80 to 40 BPM 7 sec Time to alarm for tachycardia Section 6 8 2 bb 6 Waveform B1 Amplitude Time to alarm 0 5 mV 1 sec 1mV 1 sec 2mV 1 sec Waveform B2 Amplitude Time to alarm 1mV 1 sec 2mV 1 sec 4mvV 1 sec Pacemaker pulse display capability See IEC 601 2 27 clause 50 102 12 The EG01010 is capable of displaying the ECG signal in the presence of pacemaker pulses with amplitudes of 2 mV to 700 mV and durations of 0 1 ms to 2 0 ms An indication for the pacemaker pulse is provided Version1 02 22 04 2013 8 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Pacemaker pulse rejection See IEC 601 2
9. anything except the patient cable must be made on the patient cable input side of the module see drawing on the next page With a three lead cable the module can output the following channels or II or Ill The isolated ground of the module is switched to the unused electrode in the respective setting e g isolated ground is on the left leg electrode if the module is set to channel left hand electrode if module is set to channel II and right hand electrode if channel Ill is selected Only one curve at a time can be measured e g Einthoven or II or Ill Version1 02 22 04 2013 4 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Description of the Module and Connectors Mounting Holes Connector Respiration Board x ofofo fofo O a a i 5 Te 10 F5 C23 Patient Cable Connector 900000000000 Host amp Power Connector a Patient Isolation Connector Respiration Board
10. espiration detection Output Protocol Connector 88 mm x 53 mm see page 4 for board drawing 4 layer PCB thickness 1 5 mm 12mm 25 mm four M2 5 screws in the corners of the PCB 32g 5 Volt 10 45 mA 225 mW while measuring Defibrillation protected CF 4000 Volts RMS Three levels user selectable Three frequencies user selectable Integrated 50 Hz or 60 Hz notch filter 0 05 to 70 Hz 30 248 bpm 1 1 Digit 8 beat average 5 99 rpm 3 1 Digit 8 samples average option Asynchronous serial output with CMOS levels 0 5 V Hardware pulse trigger output CMOS levels 0 5 V Both outputs fully isolated from patient Standard bidirectional serial protocol see description on following pages Connectors compatible to Medlab EG05000 five channel OEM board Optional connectors for Medlab 00731 respiration board Version 1 02 22 04 2013 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Connectors see attached drawing for location Header for host connection JP1 OMAN O O1 ND Ground Ground Txd RS232 level 5Volt Txd TTL level Rxd RS232 level 5Volt Rxd TTL level Notconnected Notconnected Notconnected Notconnected Pulse Trigger output Pulse Trigger output Shutdown VCC level on this pin powers down module Shutdown VCC level on this pin powers down module VCC input VCC input Note The pulse trigger is a high
11. ications that require to synchronize other devices to a patient s R wave The ECG wave sample points are transmitted continuously with 50 100 or 300 bytes per second according to the user s last command The curve sample points lie between 0 and 246 with the neutral line of the ECG being at 128 Values that are higher than 246 OxF6 are used for marking the following byte as a new data values according to the following definition Marker byte Meaning of following byte s Commands accepted by the module wave sample points follow N normal operation mode M switch to simulation mode S 0 send ECG trace with 300 Hz Respiration rate follows od send ECG trace with 100 Hz optional respiration board S 2 send ECG trace with 50 Hz needs to be present A o amplification stage 0 A 1 amplification stage 1 Pulse value follows A 2 amplification stage 2 G 0 channel III Info byte follows G 1 channel Il G 2 channel The only info byte D 0 show ECG curve Oth be added in th flue Mb cca Ba 5 turn on 50 Hz notch filter 6 turn on 60 Hz notch filter nG calibrate send 1mV pulse T 0 Pulse trigger 15 ms after R Spey Pulse trigger 50 ms after R A 2 Pulse trigger 100 ms after R T 9 Pulse trigger middle between R P 0 Pacemaker detection off a Pacemaker detection on Example transmitted data stream Wave Marker Wave Samples Pulse 120 Wave Marker Wave Samples OxF8 0x20 0x23 0x25 Ox
12. med Three Lead ECG OEM board EGO1010 Technical Manual Copyright Medlab 2008 2013 Version 1 02 Medlab GmbH oemsales medlab gmbh de www medlab gmbh de Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Table of Contents Mechanical Dimensions 4 Overview 4 Description of the Module and Connectors 5 Physical Units of Transmitted Data 5 Specifications 6 Connector Assignment 7 Compliance with IEC60601 2 27 8 Software Protocol Description 10 Serial Transmission 10 Serial Transmission Protocol 11 Commands accepted by the Module 12 PC Test Program 14 Regulatory Considerations 15 Document Revisions 15 3 Version 1 02 22 04 2013 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Mechanical Dimensions of the Module
13. ne with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of zero bpm Asystole b For single ventricular only pacemaker pulses with normally paced QRS T with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of the QRS T rhythm 60 bpm c For single ventricular only pacemaker pulses with ineffectively paced QRS pattern with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of the underlying QRS T rhythm 30 bpm d For atrial ventricular pacemaker pulses alone with 0 1 and 2 0 ms pulse widths and 2 mV and 700 mV pulse amplitudes the EG01010 correctly displays heart rate of zero bpm Asystole 9 Version 1 02 22 04 2013 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Serial Transmission The normal connection to the board is done via serial asynchronous communication at 9600 baud 8 data bits no parity bit and one stop bit Both CMOS and RS232 5 Volt level voltage levels are available This protocol is token oriented Special marker bytes that are not present in the normal data stream mark the meaning of the following byte The RS232 voltage levels are helpful during evaluation of the board which can be done using an ordinary PC and a special software The connection in the customer s final system could be done through
14. ne frequency yo 50Hz Filter on 6 60 Hz Filter on Selecting the transmitted waveform D Parameter 0 or 1 0x44 0x30 for example for DO 0 Show ECG trace reset value 1 Showrespiration waveform optional respiration board needed Calibration mode 1mV rectangle transmitted for 250 samples C output 250 samples of 1 mV rectangular waves then go back to normal mode Simulated data outputs useful for testing or exhibitions M use simulated outputwaves and values N use real input for data transmission reset value Version1 02 22 04 2013 12 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Set delay of the pulse trigger signal active high 33 ms duration I Parameter 0 1 2 or 9 0 Delay of the pulse trigger signal 15 ms resetvalue 1 Delay of the pulse trigger signal 50 ms 2 Delay of the pulse trigger signal 100 ms 9 The signal triggers in the middle betw een R waves Pacemaker detection on or off P Parameter 0 1 0 Pacemaker detection off 1 Pacemaker detection on reset value 13 Version 1 02 22 04 2013 Medlab GmbH Three Lead ECG OEM Module EG01010 User Manual Test Program Eile Por Tone 000 Pulse 1 min Resp 1 min EG01010 only NoDaa Data anre medlab Speed Amplitude Mode Filter Calibrate Channel EG01000 only EG01010 onty EG01010 only
15. ontains the module However several products on the market have successfully passed this certification The module complies with the following standards as far as applicable IEC60601 1 IEC60601 1 2 IEC60601 1 4 IEC60601 2 27 2005 ANSI AAMI EC13 2002 ANSI AAMI EC57 1998 During testing and certification of a product also the user manual of the final product needs to be certified The user manual has to contain certain technical data and warnings to the end users We can support customers by supplying material for the manual that has been used during the certification process of Medlab s devices Document Revisions Rev 1 00 Initial version Rev 1 01 Corrected typing errors changed manufacturer address Rev 1 02 Corrected some values on p 12 15 Version 1 02 22 04 2013 Medlab medizinische Diagnosegerate GmbH Helmholtzstrasse 1 76297 Stutensee Karlsruhe Germany Tel 49 0 7244 741100 oemsales medlab gmbh de www medlab gmbh de
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