MP01000 - Medlab GmbH
Contents
1. Bytecount 0x0 Bytecountmodifier 0xAO ACK block address 0x40 Default block address 0x200 ERRFRAME block address 0x41 ERRTOUT blockaddress 0x42 ERRCRC blockaddress 0x43 ERRCOM blockaddress 0x44 Note for acknowledge blocks data block is always of length zero 26 Medlab GmbH MP01000 User Manual ECG commands All commands have a three byte structure First byte is always E the second byte and third byte are described below Basic Bandwidth of ECG amplifier Diagnostic or Monitoring mode FO bandwidth of the amplifier DC 80 Hz Diagnosticmode bear in mind mains filter setting F1 bandwidth of the amplifier 0 67 40 Hz Monitoringmode reset value Transmission frequency of the waveform packet S0 send waveform packets 50 times per second S1 send waveform packets 100 times per second reset value S2 send waveform packets 150 times per second S7 send waveform packets 300 times per second Amplification ofthe waveforms AO Amplification stage 1 lowest amplification should be scaled to 0 5 cm mV A1 Amplification stage 2 reset value A2 Amplification stage 3 A3 Amplification stage 4 highest amplification should be scaled to 4 cm mV Each amplification stage has double the sensitivity of the previous stage Channel selection 1 8 wave channels can be selected Cx Each bit in byte x set to 1 stands for a transmitted wave a2. 0 means that wave is not transmitted 10000000 respiration 01000000 C1 00100000 aVF 00010000 aVL 00001000 aVR 00000100 Ill 00000010 II 00000001 Example to receive aVR and respiration send 0x45 character E 0x43 character C 0x89 Filtering of the waveforms for 50 and 60 Hz line frequency 50 50 Hz and 60 Hz Filter off 51 50HzFilteron reset value 52 60 HzFilter on Filtering of the waveforms for EMG interference 15 30 Hz E0 EMG Filter off reset value E1 EMG Filter on 27 Medlab GmbH MP01000 User Manual Set board to adult mode or neonate pediatric mode NO board is in adult mode reset value N1 board is in pediatric neonate mode Calibration mode 1mV rectangle transmitted for 250 samples KO output 250 samples of 1mV rectangular waves then go back to normal mode Update electrode configuration Recognizes newly connected electrodes q0 Newly connected electrodes are recognized after this command has been sent to the module Also any other command except K and I starts a new search for connected electrodes Simulated data outputs useful for testing or exhibitions MO use real input for data transmission reset value M1 use simulated output waves and values Pacemaker detection on or off PO do not detect pacemaker pulses P1 detect pacemaker pulses reset value Set delay of the pulse trigger signal
3. Four data output rates user selectable 50 Hz 60 Hz or no notch filter EMG filter can be turned on or off 0 05 to 70 Hz Adult and neonatal mode Diagnostic and monitoring mode 0 67 Hz monitoring or 0 05 Hz diagnostic 40 Hz monitoring or 70 Hz diagnostic 30 247 bpm 1 1 Digit 12 beat average 5 99 rpm 3 1 Digit 8 samples average option Pacemaker detector 2mV to 700mV 0 5 2ms pulse width can also be turned off Separate adjustable pulse trigger output 0 5 V level Trigger output also fully isolated from patient side Medlab GmbH SpO 2 Measuring range SpO 2 Accuracy SpO Averaging SpO Measuring range pulse Accuracy pulse rate Averaging pulse rate NIBP Meas range for adults Meas range for neonates Accuracy abs pressure Accuracy algorithm Pulse rate range Leakage rate Overpressure limits Temperature Channels Probes Accuracy Measurement range Warm up time MP01000 User Manual 0 100 of SpO 90 100 1 1 digit 80 89 2 1 digit 70 79 3 1 digit 70 100 2 1 digit below 70 not specified user selectable in three stages 30 249 bpm of pulse rate 1 1 Digit follows SpO averaging SYS 25 280 mmHg DIA 10 220 mmHg MAP 15 260 mmHg SYS 20 155 mmHg DIA 5 110 mmHg MAP 10 130 mmHg 2 mmHg lt 5 mmHg for mean value
4. clinical validation has been done with these cuffs Temperature probes All probes that are compatible with the YSI 400 family resistance specifications can be used However the manufacturer of the probe should be selected with care as the accuracy of the clinical thermometer directly depends on the accuracy of the temperature resistance curve of the probe Medlab GmbH Specifications General Mechanical size Maximum height Attachment Weight Operating voltage Power consumption Temperature Humidity ECG Input ECG Patientisolation Leakage current Amplification Data transmission Mains filter Other filters Amplifier frequency range Age modes ECG modes Lower edge frequency Upper edge frequency QRS detection Respiration detection Pacemaker Output MP01000 User Manual 110 mm x 100 mm 4 layer PCB thickness 1 6 mm 33 mm without ECG respiration option 40 mm with respiration option four M3 screws in the corners of the PCB 175g 7 15 V DC 980 mW while NIBP not measuring with respiration 940 mW while NIBP not measuring without respiration max 2000 mW during NIBP pump up max 1200 mW during NIBP measurement pump off Storage 30 C to 90 C Operation 20 C to 50 C Storage 0 95 non condensing Operation 5 95 non condensing Defibrillation protected 4000 Volts RMS Better than class CF requirements lt 10 HA Four stages user selectable
5. 4 0 AC DC ratio 110 4 0 8 0 AC DC ratio 111 gt 8 0 AC DC ratio Quality Q3 Q0 Quality is a number between 0 and 10 coded into the lower four bits of status byte 2 If the number is 0 ten or more consecutive pulses have been detected without artefact or other problems Zero therefore means best quality 19 Medlab GmbH MP01000 User Manual NIBP Blocks Measurements of NIBP must be individually started by sending the relevant command to the NIBP board Alternatively the board can be set to cycle mode Then a measurement is automatically started after the selected time frame has passed For measurements on neonates the board must be set to neonatal mode For adults children and infants the board should be set to adult mode During measurement the current cuff pressure is transmitted five times per second and can be used to indicate cuff pressure to the user with a bargraph or a similar indicator on the user interface ofthe device During measurement a break command immediately stops measurement and deflates the cuff Directly after a measurement has ended a NIBPNUM block is transmitted together with a status block If errors have been detected during measurement the pressure values and pulse rate in the NIBPNUM block are set to zero NIBPNUM and status blocks are then repeated every ten seconds Also sent every ten seconds is a NIBPTIMERBLOCK This block indicates how old the values in the NIBP
6. 700 mV pulse amplitudes the MP01000 correctly displays the heart rate of the underlying QRS T rhythm 30 bpm for the specified test waveform Medlab GmbH MP01000 User Manual Serial Transmission The host connection to the board is a serial communication interface By default transmission is over an asynchronuous UART style interface operating at 115200 baud 8 data bits no parity bit and one stop bit Both CMOS and RS232 5 Volt level voltage levels are available on the connector The RS232 voltage levels are helpful during evaluation ofthe board which can be done using an ordinary PC and a special software The connection in the customer s final system will typically be done through OV 5V levels which saves electronic components on the host side of the data stream Optionally the board can also communicate with the host over a CAN interface at 250k 500k and 1000k bit transmission rate The MP01000 sends data and receives commands For both CAN and UART mode the protocol is block oriented In UART mode the block begins with a start sequence consisting of a start character a one byte data length counter and a 16 bit block identifier This header is followed by a payload block of zero to 8 bytes length The payload data is followed by a one byte CRC checksum and an end character Transmission can be started and stopped with TXDON and TXDOFF command sent by the host In UART mode the module starts sending data autom
7. a timeout period of 5ms gt no gt timeout error 2 Requirements of the general structure of the command block fulfilled gt no gt frame error 3 Byte counter of the data block set to three bytes gt no gt frame error 4 CRC of the data block correct gt no gt CRC error 5 Are the three bytes of the data block a valid command gt no gt unknown command error this can be checked for UART mode only in CAN mode blocks that do have false CRC s are suppressed by the CAN controller of the board The host CAN controller resends the command block in case of CRC errors If all requirements are fulfilled the board answers with an ACK block see below for description In all other cases a specific error block as described above is sent back to the host Example The host wants to set the ECG speed to 300 samples per second Block identifiers have their default value Host sends command frame 0x02 0xA3 0x00 0x03 0x45 0x53 0x37 OxEC 0x03 Board returns an ACK frame 0x02 0xA0 0x40 0x02 0xD6 0x03 Board changes ECG setting Command Block Host gt MP01000 Header Data Block End Bytecount 0x03 Bytecountmodifier 0xA0 X B X 5 XM X 0 ECG command address 0 Default command address 0x300 SPO2 command address 1 NIBP command address 2 TEMP command address 3 MULTIPAR command address 4 TXONOFF command address 5 Command Acknowledge Blocks MP01000 gt Host Header End
8. active high 33ms duration 10 Delay of the pulse trigger signal 15ms reset value 11 Delay of the pulse trigger signal 50ms T2 Delay of the pulse trigger signal 100ms T9 The signal triggers in the middle between R waves SpO Commands All commands have a three byte structure First byte is always S the second byte and third byte are described below Transmission speed of plethysmogram S0 send 50 waveform blocks per second S1 send 100 waveform blocks per second reset value Averaging of the SpO value A0 low averaging e g fast SpO reaction A1 medium avaraging of SpO reset value A2 strong averaging of SpO value NIBP Commands All commands have a three byte structure First byte is always N the second byte and the third byte are described below 28 Medlab GmbH MP01000 User Manual Start a new measurement 51 Stop an active measurement cycle immediately XX Adjust automatic cycle mode C0 cycle mode off reset value C1 cycle mode 1 minute C2 cycle mode 2 minutes C3 cycle mode 3 minutes C4 cycle mode 4 minutes C5 cycle mode 5 minutes C6 cycle mode 10 minutes C7 cycle mode 15 minutes C8 cycle mode 30 minutes C9 cycle mode 60 minutes Note the module must be started with a S1 command and perform one successful measurement to actually enter cycle mode thereafter Set
9. an amplitude of 1 mV The detection range of QRS amplitudes is 0 5 mV to 5 mV for durations of the QRS complex ranging from 50 ms to 120 ms up to a signal rate of 300 BPM If the MP01000 is set to neonatal mode the detection range of QRS amplitudes is 0 5 mV to 5 mV for durations of the QRS wave ranging from 40 ms to 120 ms up to a signal rate of 350 BPM Response to irregular rhythm Section 6 8 2 bb 4 A1 Ventricular bigeminy the MP01000 counts both large and small QRS complexes to display a rate of 80 bpm A2 Slow alternating ventricular bigeminy the MP01000 counts both large and small QRS complexes to display a rate of 60 bpm A3 Rapid alternating ventricular bigeminy the MP01000 counts all QRS complexes to display a rate of 120 bpm A4 Bi directional systoles the MP01000 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 2 mV 1 sec Waveform B2 Amplitude time to alarm 1mV 1 sec 2 mV 1 sec 4mV 1 sec Medlab GmbH MP01000 User Manual Pacemaker pulse display capability See IEC 601 2 27 clause 50 102 12 The MP01000 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 5 ms to 2 0 ms An indication fo
10. start pumpup pressure PO set start pumpup pressure 100 only neonatal mode P1 set start pumpup pressure 120 only neonatal mode P2 set start pumpup pressure 140 reset value P3 set start pumpup pressure 160 only adult mode P4 setstart pumpup pressure 180 only adult mode Setmode NO setadultmode reset value N1 setneonatalmode Startmanometer mode M1 startmanomater mode Startleakage test L1 startleakagetest Temperature Commands All commands have a three byte structure First byte is always T the second byte and the third byte are described below Settransmission speed S0 send one data block per second reset value S1 send five data blocks per second 29 Medlab GmbH MP01000 User Manual Multiparameter Commands All commands have a three byte structure First byte is always M the second byte and the third byte are described below Serialnumber PN the MP01000 returns a 32bit serial number in a 4 byte data block See page 25 Status PS the MP01000 returns board status in a 5 byte data block See page 25 Note the error counters are reset after transmission of the status block Version number PV the MP01000 returns firmware version number info in a 4 byte data block See page 25 Transmission on off sTo serial data transmission off reset value for CAN interface mode Ei serial data transmission on reset val
11. 0 0000 00 10000000 Tak CRC Send Command CRC ST 0443 003 0415 EC sua _crc Send ST 0xA3 0x24 x15 N ET RC avraylava I 4 6 F ack CRC Send Block count _ SpO2 wove CRC CAC errors Jouuocooo foo oo foooo0000 Block count _ SpO2 num dec CRC CRC errors Black count _ Tamgersturs num dec CRC CRC errors 00000000 foo o0 oc 00000000 00000000 foo 0 009000 oo 00000000 Block count _ SpO2 stat CAC CAC errors Black court _ Tamereturs stot CRC CRC errors 00000000 00000000 foo 0900000 ODDO 00 00 00 fou 00000900 Command CRC Commend CRC lt STO OAI 0x13 0x15 S EnO lt STX gt WAS 0633 DIS T EC M Ak c sem Tak CRC _Send Block count Board stat RC CRC errors ECG Base Addrass Base Address CMD Base Address foooooooo fon foo 00000000 fioo zoo aoc Block count Soard version CRC CRC errors foooooooo foo o0 o0 00 foo 00000000 ENS PDON lt STX gt OxAS Dx53 Ox15 M ETO Block court _ Board sernum CRC CAC errors foooooooo fon 0000 00 oo 00000000 Tow 6 F Ak cac _send Select the COM port the MP01000 is connected to You should now already see data coming in Try sending an ECG command by either entering one of the commands described on page 27 into field or by selecting several of the ECG traces you want to receive in the tick boxes Press the CRC button to generate the CRC for the command and press the send button 6 If the command is recognized an ACK block is returned and the tick box i
12. Chest electrode 2 SHIELD Patientground 3 LL IN Left Leg electrode 4 RA IN Right Arm electrode 5 LA IN Left Arm electrode 6 SHIELD Patientground 7 RL IN Right leg electrode Medlab GmbH MP01000 User Manual Patient Cable Connection ECG cable The module can be connected to the patient using a three lead four lead or five lead ECG cable Depending on cable one to seven channels of ECG can be measured Three Lead Patient Cable Four Lead Patient Cable Five Lead Patient Cable A I Shield E go lE Lor Il or Ill I and Il and Ill I and Il and Ill and aVL and aVR and aVF and aVL and aVR and aVF and C SpO Transducer The module can work with all Medlab PEARL SpO probes There are reusable as well as disposable types Please see the separate catalog available for the probes The module cannot work with other manufacturers SpO probes The probes have a male DSUB 9 connector that needs to be connected to the board using an adapter between connector X5 and the probe plug For prototypes these adapters are available from Medlab For series production as each device requires another length you should produce your own adapter cables Also flexible PCBs are a good solution for this adapter NIBP Cuffs While it is not mandatory to use Medlab cuffs for NIBP measurement best accuracy is reached when using them as the module s algorithm is developed for the mechanical dimensions of the bladders in the NIBscan cuffs Also
13. DO 1 76 2 50 8 56 Le 105 2 Eoo Medlab GmbH MP01000 User Manual Module Connectors Le 106 7 All units in mm ofsi g ooo00n GEET mig eo O gm gag LEMP BE th BE g a fk nog a 5 ac o BE E m o oo Q a pL fe mGoon o 8 SpO2 lao o MNT imm o X5 nn D o an 3 a TE Jo o JP2 Mio CAN J1 T ER 18 ECG x1 G e e x6 ont it 2 a UART 20 2 X2 oo O e oo 2 LI a ite e a POWER 91 x3 o Le X1 CANconnector 1 CANH CAN bus high line 2 CANL CAN bus low line 3 GND System ground note closing JP2 adds a termination resistor to the CAN bus The test kit version of the board comes with connectors X2 X6 populated with 90 angled male connectors The boards for serial production alone are delivered without any connectors populated in order to enable the user to use the type of connector he needs for his application DXF data of the board is available upon request X2 UART connector GND GND TxD CMOS level TxD RS232 level RxD CMOS level RxD RS232level notconnected ISP GND 10 GND 11 R TRIG 12 R TRIG 13 notconnected 14 notconnected 15 notconnected 16 notconnected OANDOaARWHND System ground System ground Serial data output Serial data output Serial data input Serial data input In system programming used for firm
14. NUMBLOCK are It is a common feature of monitors to blank out measurements that are older than a certain amount of time not to mislead the user about the current NIBP values ofthe patient that might be already totally different The second value in the timer block indicates the time until the next measurement is automatically started when in cycle mode NIBP Blocks NIBPCURRENTCUFFPRESSURE BLOCK 2 bytes long Byte 1 16 bit value of current pressure in NIBP cuff in mmHg low byte part Byte 2 16 bit value of current pressure in NIBP cuff in mmHg high byte part NIBPCURRENTCUFFPRESSURE BLOCKS are only transmitted during ongoing measurements 5 times per second NIBPNUM BLOCK 7 bytes long Byte 1 16 bit value of measured systolic pressure in mmHg low byte Byte 2 16 bit value of measured systolic pressure in mmHg high byte Byte 3 16 bit value of measured mean arterial pressure in mmHg low byte Byte 4 16 bit value of measured mean arterial pressure in mmHg high byte Byte 5 16 bit value of measured diastolic pressure in mmHg low byte Byte 6 16 bit value of measured diastolic pressure in mmHg high byte Byte 7 8 bit value of measured pulse rate in bpm 1 min NIBPNUM BLOCKS are transmitted after each measurement and then every ten seconds 20 Medlab GmbH MP01000 User Manual Byte 1 16 bit value time passed since last measurement in seconds low byte Byte 2 16 bit value time passed since last measurement in se
15. age explains the meaning of the different stages of perfusion This is important because the plethysmogram is automatically scaled Therefore the height of the plethsymogram is not a direct indication for the perfusion at measurement site If no finger is in the probe or no probe is connected the waveform transmitted is a flat line The value package and the status package are in this case transmitted once per second Oxygen saturation and pulse rate are set to zero and the info byte contains either the No sensor or No signal info 18 Medlab GmbH MP01000 User Manual SpO2 Blocks SPO2WAVE BLOCK 1 byte long Byte 1 8 bit sample value plethysmographic waveform in straight binary neutral line at 0x80 SPO2WAVE blocks are transmitted 100 times per second SPO2NUM BLOCK 2 bytes long Byte 1 8 bit SpO2 value in Byte 2 8 bit pulse rate value in bpm e g 1 min SPO2NUM blocks are sent once after each detected pulse and can also be used to generate a pulse beep on the host SPO2STAT BLOCK 3 bytes long Bit7 Bit 6 Bit5 Bit 4 Bit 3 Bit2 Bit 1 Bit 0 SPO2STAT blocks are sent once after each detected pulse Status Perfusion S6 S0 P2 PO 0000000 0x00 OK 000 unused 0000001 0x01 No probe detected 001 lt 0 25 AC DC ratio 0000010 0x02 No finger in probe 010 0 25 0 5 AC DC ratio 0000011 0x03 Low perfusion 011 0 5 1 0 AC DC ratio 1000101 0x45 Selftest error 100 1 0 2 0 AC DC ratio 101 2 0
16. atically after power up and selftests are finished In CAN mode the content of the payload block is identical to the data blocks in UART mode but the role of the block identifier mentioned above is actually taken over by the 11 bit CAN identifier Since the multiparameter board generates a lot of data priority of the CAN identifiers have to be relatively high this means low values for identifiers and consequently only 11 bit identifiers are supported Of course other devices on the CAN bus can use 29 bit identifiers transparently CRC bytes start of block and end of block as well as data length code are handled automatically by the CAN bus controller of the host Transmission can be started and stopped with TXDON and TXDOFF command sent by the host In CAN mode the module does not start to send automatically after power up Instead it waits for the first TXDON command please see description on page CAN mode is more complicated compared to UART mode so if your application does not require CAN for technical reasons we recommend to work using UART mode The CRC checksum of each block also enables a very reliable and secure data transmission in UART mode The neutral line of all waveforms is located at 128 0x80 since the module transmits unsigned data If blocks contain numbers of more than 8 bits length the lower byte is always transmitted first in the block little endian To set the board to either CAN or UART mod
17. conds high byte Byte 3 16 bit value time until next measurement in seconds low byte 0 if no cycle mode active Byte 4 16 bit value time until next measurement in seconds high byte 0 if no cycle mode ac NIBPTIMER BLOCKS are transmitted after each measurement and then every ten seconds NIBPSTAT BLOCK 4 bytes long Bit7 Bit 6 Bit5 Bit 4 Bit 3 Bit2 Bit 1 Bit 0 Byte 1 Byte 2 Byte 3 Byte 4 State S2 S0 000 Auto test in progress only during boot 0 Adult mode 001 Wait for command no cycle mode 1 Neonatal mode 010 Error see bits E3 E0 for details 011 Measuring in progress 100 Manometer mode 101 Initializing 110 Reserved C6 CO 111 Leakage test in progress 0000000 0x00 0 No cycle selected 0000001 0x01 1 1 minute cycles selected 0000010 0x02 2 2 minutes cycles selected 0000011 0x03 3 3 minutes cycles selected Error 0000100 0x04 4 4 minutes cycles selected E3 E0 0000101 0x05 5 5 minutes cycles selected 0000 0x00 No error 0001010 Ox0A 10 10 minutes cycles selected 0001 0x01 Reserved 0001111 OxOF 15 15 minutes cycles selected 0010 0x02 Autotest failed 0011110 Ox1E 15 30 minutes cycles selected 0011 0x03 No error 0111100 0x3C 60 60 minutes cycles selected 0100 0x04 Reserved 1011010 0x5A 90 90 minutes cycles selected 0101 0x05 Reserved 0110 0x06 Cuff fitted too loosely or not connected 0111 0x07 Leakage including sudden occurance 1000 0x08 Faulty slow loss of pressu
18. e and to set the CAN speed and the block identifiers please refer to the chapter Board setup of this manual After delivery the board defaults to UART mode base address ECG 0x0100 base address data blocks 0x0200 and base address for command blocks 0x0300 Medlab GmbH MP01000 User Manual UART mode block Header Data Block Payload data End STX Start of block character 0x02 Bytecount Number of bytes in the data block plus OxA0 E g OxA5 is 5 bytes Identifier Each type of data block uses another block identifier Must be lt 2048 same as Object identifier for CAN Data The data to be transmitted variable length Command acknowledge or error blocks have a data length of 0 CRC8 checksum of the 4 byte header and the data block Polynom x 8 xN 5 x 4 xN0 ETX End of block character 0x03 CAN mode block Data Block Payload dai ta Data 1 8 Byte i DLC Data length code number of bytes in the data block Host reads this from his CAN controller Object Identifier CAN bus address also sets priority of data block Host reads this from his CAN controller Data CAN bus data block Host reads this from his CAN controller UART Interface The host UART has to be initialized for a baud rate of 115200 baud 8 data bits no parity bit and one stop bit The host has to wait for the STX character verify that the next byte is a valu
19. e between OxA0O 0 byte block length and 0xA8 8 bytes block length and then receive the full data block After this the host has to generate the one byte CRC checksum from the STX character to the last data block byte and compare the result with the received CRC byte If they have the same value the block is valid The host can then decode the received block according to the detailed descriptions of the data block content on the following pages The polynom used for the CRC generation is x48 x45 x44 x40 Since the bases addressed in UART mode do not have any special meanings for priorities as the object identifiers in CAN mode have it does not make a lot of sense to set them to custom values Itis however possible Transmission of data can be completely turned off by the TXDOFF command and reenabled by the TXDON command The board board defaults to TXDON after power up CAN Interface The host CAN controller has to be initialized to 250k 500k or 1000k bit speed and the object identifiers described on the next pages have to be added to the acceptance filter of the host s CAN controller The host then has to issue a TXDON command and will then start to receive data blocks The host has to wait for his CAN controller to signal a successful reception of a CAN block The host can then decode the received block according to the detailed descriptions of the data block content on the following pages The board defaults to TXDOFF after pow
20. e following channels or II or II The non invasive blood pressure measurement is done using a standard cuff normally fitted on the left upper arm of the patient There are six different cuff sizes available SpO is measured using an optical transducer that is attached to the patient s finger Medlab offers a complete family of transducers reusable and single use types for adults and neonates Temperature is measured using standard YSI400 family temperature probes The MP01000 contains all patient side electronics needed for a complete and small medical multi parameter monitor The module communicates with a host over a bidirectional serial interface either of UART or CAN type The MP01000 receives commands from the host and streams the measured patient data back to the host microcontroller Both sides of the protocol are block oriented and secured by a CRC checksum present in the data blocks Since the module generates a relatively large amount of data a powerful 32 bit host microcontroller is required For example ARM Cortex M3 or Cortex M4 controllers are very well suited to receive and decode the data stream and also eventually control a user interface on a colour LCD or similar Medlab GmbH MPO1000 User Manual Mechanical Dimensions T T All connectors 2 54mm spacing ECG connector 5 12mm spacing 49 5 39 4 000 00000000 oon 20000000 0000007 000000 1 gt
21. emperature channel 2 in C 10 low byte Byte 4 16 bit value of measured temperature channel 2 in C 10 high byte Byte 5 16 bit value of measured temperature in reference channel in C 10 low byte Byte 6 16 bit value of measured temperature in reference channel in C 10 high byte TEMPNUM blocks are sent once per second or five times per second depending on the last temperature speed command Power on default is 1 block per second TEMPSTAT BLOCK 3 bytes long Byte 1 8 bit value status channel 1 Byte 2 8 bit value status channel 2 Byte 3 8 bit value status reference channel TEMPSTAT blocks are sent once per second Status 0000000 0x00 OK 0000001 0x01 No probe detected 0000010 0x02 Temperature too low 0000011 0x03 Temperature too high 0000100 0x04 Calibration lost 23 Medlab GmbH MP01000 User Manual Status Blocks The MP01000 has a few blocks that are not related to a parameter but rather refer to the module in general general blocks They are only transmitted after they have been requested by the user They include individual serial number of the board status of the board and firmware versions of the different subsystems For details please see the following page 24 Medlab GmbH MP01000 User Manual General Blocks GENERALSTAT BLOCK 6 bytes long Byte 1 8 bit value internal use only Byte 2 8 bit value internal use only Byte 3 8 bit value internal u
22. er up Object Identifiers CAN Identifier low high UART Because the object identifiers in CAN mode are directly responsible for the priority of the message on the bus the basic address of the identifiers can be set by the user in three groups ECG block base address host block base address and command block base address This has been split into three groups the ECG blocks should have the highest priority lowest identifier because the amount of data sent is largest for the ECG wave blocks The second user adjustable address is the base address for all data blocks to the host except the ECG blocks and the third address is the base address used for commands sent to the board by the host Medlab GmbH MP01000 User Manual Serial Transmission Protocol After the host has received the blocks either over UART or CAN interface the data block descriptions on the next pages can be used for decoding ECG Blocks The board transmits up to 7 ECG waveforms and an impedance respiration waveform The transmitted channels that are available with a five lead cable are 1 I Einthoven Lead 2 Il Einthoven Lead 3 Ill Einthoven Lead 4 aVR Goldberger Lead 5 aVL Goldberger Lead 6 aVF Goldberger Lead 7 Ci one Wilson lead that should be placed on the chest of the patient 8 Respiration curve The module works with a three lead a four lead or a five lead cable Only parts of the maximum number of channels can be measured
23. ets the form entries to the delivery values of the MP01000 One must press the program button afterwards to reprogram these settings into the board s EEPROM memory though If you are using the UART mode to interface to the board there is no reason to use this tool the block identifier addresses in UART mode do not have an additional influence as they have in CAN mode where they are directly responsible for the priority of the respective message 31 Medlab GmbH MP01000 User Manual Test Program A Microsoft Windows program Multiparam exe is available for getting used to operate the board The program does not need installation just copy it to a directory of your choice and run it It requires MS NET 2 0 The software allows to see all received data blocks and waveforms It is also possible to send commands within this program lab Multiparameter paesane Block count ECG wave CRC CRC errors Block count NIBP cuff pressure dec CRC CRC errors foooooooo fon 00 00 00 00 09 09 00 foo 00000000 foo000000 Jon foo 00000000 Block court ECG num dec CRC CRC errors Block count NIBP num dac CRC CRC errors 00000000 000 00 oo 00000000 00999000 000 000 000 000 00 00000000 Block court ECG stat ORC CRC errors Block count NIBP stot CRC CRC errors 00000000 0 00 00 00 oo 00000000 00999000 00 00 00 00 20 00000000 Command CRC Bock court NIBP timer CRC CRC errors lt STX gt OAI 0409 0x15 E 2 Ex 00000000 000
24. ge of 0 OxFF It is within the responsibility of the user to scale the transmitted samples in a way so the waves displayed on his individual 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 Medlab GmbH MP01000 User Manual Stage 1 Stage 2 Stage 3 Stage 4 1mV 32 1mV 64 1mV 128 1mV 256 Respiration rate is transmitted in rpm respirations per minute Pulse rate is transmitted in bpm beats per minute Pressures for NIBP are transmitted in mmHg 1mmHg 133 322 Pascal Temperatures are transmitted in 10 C e g 388 equals 38 8 C Overview The MP01000 contains a five lead ECG a pulse oximeter a part for measuring a patient s arterial blood pressure none invasively and a two channel thermometer The module can work with a five lead ECG cable to show 7 channels of ECG with a four lead cable showing 6 channels and with a three lead cable to show one channel of ECG An advanced pulse detection algorithm is integrated The module measures the respiration rate of the patient using the impedance change between the electrodes When using a five lead cable the module can output the following channels synchronously I Il Ill aVR aVL aVF C When using a four lead cable the module can output the following channels synchronously I Il Ill aVR aVL aVF When using a three lead cable the module can output th
25. ger te GmbH Helmholtzstrasse 1 76297 Stutensee Karlsruhe Germany Tel 49 0 7244 741100 oemsales medlab eu www medlab eu
26. if not all five electrodes are connected see page 7 The board contains a lead off detection that gives information about each single non connected electrode It is not possible for the module to automatically detect which ECG cable is connected since the situation is the same whether for example a three lead cable or a five lead cable with two non attached leads is used It is recommended for the user to use a connection system with coded cables shorted unused pins in the connector for example to make the host system aware of which cable style currently is connected to the ECG part and to ignore lead off messages that do not exist for the respective cabling system The simplest solution is to have the end user select which cable is connected in a menu entry in the host s user interface Channels that are requested by the host but cannot be measured because of no electrode contact or the respective lead missing in the cable are transmitted as 0x80 neutral line The module features an adult and a neonatal mode In adult mode pulse rates up to 300 bpm are detected Pulse rates of more than 248 are output as 248 bpm QRS complexes of 50 ms width and less are not counted as pulses In neonatal mode pulse rates up to 350 bpm are detected and rates of more than 249 are output as 248 bpm QRS complexes of 50ms down to approximately 20 ms width are counted as pulses These differences in adult and neonatal pulse detection are a requirement
27. ked FDA registered or safety tested in a test lab Glossary ECG Electrocardiogram Lead Connection to the patient and one ECG electrode Channel Waveform showing the differential voltage between two or more electrodes BPM Beats per minute 1 min Unit used to display pulse rates RPM Respirations per minute 1 min Unit used to display respiration rate SpO Saturation pulsatile O the arterial oxygen saturation in measured by a pulse oximeter NIBP Non invasive blood pressure measured by a cuff around the upper arm YSI400 The family of standardized temperature probes used for body temperature measurement UART Universal Asynchronous Receiver Transmitter Interface type CAN Controller Area Network Interface type Physical Units of Transmitted Data Transmission speeds for the waves are indicated in Hz sec 1 Scaling of ECGs is done in the units cm mV for the Y axis and in mm sec for the X axis Standard values for the trace speed are 12 5 mm sec 25 mm sec and 50 mm sec The amount of points needed to reach these speeds depend on the resolution of the user screen For example if one uses an LCD screen with a resolution of 4 dots mm a data rate of 100 Hz is needed to show the waveform with 25 mm sec ECG amplitudes are typically indicated in cm mV Since this is directly depending on the resolution of the screen the user is working on the transmitted samples cannot be scaled like this but instead fall into the ran
28. lt 8 mmHg standard deviation 30 230 bpm lt 3 mmHg minute 290 mmHg adult mode 150 mmHg neonatal mode 2 temperature channels 1 reference channel 38 8 C Compatible with all YSI series 400 probes 0 1 C for an ambient Temperature of 10 C to 40 C 25 0 50 0 C less than 30 seconds Medlab GmbH MP01000 User Manual Technical description for TRF IEC 60601 2 27 When preparing a test report form TRF for proof of compliance of the users medical product to IEC60601 2 27 the following remarks technical data will be helpful or needed Input Impedance gt 10 MOhm 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 EC13 1992 Leads off sensing current Applied currents less than 150 nA The following information references particular sections of IEC and EN 60601 2 27 Respiration optional Section 6 8 2 bb 1 Applied currents less than 80 HA 90kHz 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 The pulse rate is averaged over the last 12 detected pulses QRS Detection various sections If the MP01000 is set to adult mode the heart rate meter will not respond to ECG signals having a QRS amplitude of 0 15 mV or less or R waves of a duration of 10 ms or less with
29. mV pulse amplitudes the MP01000 correctly displays the heart rate of the underlying QRS T rhythm 30 bpm for the specified test waveform With over and 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 MP01000 correctly displays a 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 MP01000 correctly displays the heart rate of the QRS T rhythm 60 bpm for the specified 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 MP01000 correctly displays the heart rate of the underlying QRS T rhythm 30 bpm for the specified waveform 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 MP01000 correctly displays a 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 MP01000 correctly displays the heart rate of the QRS T rhythm 60 bpm for the specified test waveform f For atrial ventricular pacemaker pulses with ineffectively paced QRS pattern with 0 1 and 2 0 ms pulse widths and 2 mV and
30. mediab Multiparameter OEM Board for Patient Monitors MPO1000 Technical Manual Copyright Medlab 2013 Version 0 97 Medlab GmbH Medlab GmbH Helmholtzstrasse 1 76297 Stutensee Karlsruhe Phone 49 7244 741100 support medlab eu www medlab eu MP01000 User Manual Medlab GmbH Table of Content Introduction Glossary Physical Units of Data Overview Mechanical Dimensions Board Connectors Specifications General Electrocardiogram Pulse Oximeter Non Invasive Blood Pressure Body Temperature Technical Information ECG Serial Transmission UART Interface CAN Interface Protocol Description Packet Description Command Blocks Board Setup PC Test Program Regulatory Considerations Revisions of this document MP01000 User Manual oa A A FA Medlab GmbH MP01000 User Manual Introduction This document describes the hardware and the firmware interface of Medlab s multiparameter patient monitoring board the MP01000 The module can be used to construct a patient monitor to be used from neonate to adult while concentrating on housing design and user interface The MP01000 handles the complete interface to the patient in a safe and certifiable way The MP01000 is not a final medical product and carries no CE mark The module will not hinder you to confirm with the current relevant standards but also the part ofthe system added by the user has to be designed in a way so that the complete product can be CE mar
31. of the newest ECG monitoring standard The default settings after power up are 100 wave blocks per second I II II activated 1cm mV amplification monitoring bandwidth 50 Hz filter active The host can adjust this to its needs by sending commands to the module 16 Medlab GmbH MP01000 User Manual ECG Blocks ECGWAVE BLOCK 1 to 8 bytes long Identifier ECGBaseaddress 0x00 default 0x100 Byte 1 8 bit sample value curve 1 in straight binary neutral line at 0x80 Byte 2 8 bit sample value curve 2 in straight binary neutral line at 0x80 Byten note the amount of curves transmitted depend on the last curve selection command ECGWAVE blocks are sent 50 100 150 or 300 times per second depending on the last ECG speed command Power on default is 100 blocks per second ECGNUM BLOCK 2 bytes long Identifier ECGBaseaddress 0x01 default 0x101 Byte 1 8 bit pulse rate value in bpm e g 1 min Byte 2 8 bit respiration rate value in rpm e g 1 min ECGNUM blocks are sent once after each detected pulse and can also be used to generate a pulse beep on the host ECGSTAT BLOCK 4 bytes long Identifier ECGBaseaddress 0x02 default 0x102 Bit7 Bit 6 Bit5 Bit 4 Bit 3 Bit2 Bit 1 Bit 0 Byte 1 Byte 2 Byte 3 Byte 4 ECGSTAT blocks are transmitted once per second Notch filter ECG stat N1 NO ST3 STO 00 Notch filter off 0000 Normal operation 01 50 Hz filter on 0001 No
32. r the pacemaker pulse is provided Pacemaker pulse rejection See IEC 601 2 27 clause 50 102 13 Without over and undershoot rectangular pulse 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 MP01000 correctly displays the 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 MP01000 correctly displays the 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 MP01000 correctly displays the heart rate of the underlying QRS T rhythm 30 bpm for the specified waveform 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 MP01000 correctly displays a 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 MP01000 correctly displays the heart rate of the QRS T rhythm 60 bpm for the specified test waveform 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
33. re 1001 0x09 No pulse detected cuff incorrectly fitted 1010 0x0A Measurement range exceeded 1011 0x0B Movement artefacts too strong 1100 0x0C Excess pressure according to IEC limits 1101 0x0D Pulse signal too large 1110 0x0E Leakage during leakage test 1111 0x0F System error 21 Medlab GmbH MP01000 User Manual Temperature Blocks The MP01000 can be connected to up to two probes of the YSI400 temperature probe series to measure up to two body temperatures Measurement range is 20 0 45 0 C Outside this temperature window the respective channel will report a too low or too high error in the status block Also an open input is indicated in the status block The board has a status channel that always should read as 38 8 C Each board is individually calibrated and the calibration constants are stored in two copies in an EEPROM on the board If CRC check of both copies fails a calibration lost error is given in the status block This error is fatal the board has to be resent for recalibration Temperature and status blocks are sent once per second by default Using a command this rate can be increased to five blocks per second 22 Medlab GmbH MP01000 User Manual Temperature Blocks TEMPNUM BLOCK 6 bytes long Byte 1 16 bit value of measured temperature channel 1 in C 10 low byte Byte 2 16 bit value of measured temperature channel 1 in C 10 high byte Byte 3 16 bit value of measured t
34. rmal operation pacemaker detected 10 60 Hz filter on 0100 Initializing 11 reserved 0101 Searching for electrodes 1000 Simulated output 1010 Selftest error a Rest unused but reserved Amp Speed A1 AO S1 S0 00 Amplification stage 1 lowest 00 50 wave blocks per second 01 Amplification stage 2 01 100 wave blocks per second 10 Amplification stage 3 10 150 wave blocks per second 11 Amplification stage 4 highest 11 300 wave blocks per second 17 Medlab GmbH MP01000 User Manual SpO Blocks The board transmits the SpO waveform plethysmogram a data block and an Spo status block The module works with all Medlab PEARL SpO probes reusable and disposable probe types please see catalog of probes for available types After a probe is connected and a finger is detected the board sends 50 or 100 waveform blocks per second containing the plethysmographic waveform of the pulse oximeter Transmission speed of the plethysmogram can be adjusted by sending an SO or S1 command The arterial oxygen saturation and the pulse rate are transmitted once per detected pulse directly after detection took place The reception of this block can therefore be used to generate a pulse beep on the host Also the status block is transmitted once per detected pulse directly after the data block The perfusion index in the status block gives an indication for the perfusion at the measurement site The table on the next p
35. s activated Other commands are sent in the same way in the respective data fields of the different parameters Select the CURVE tab to see the ECG and SpO2 waveforms Communication can be turned on and off with the buttons next to The object identifiers the program listens to can be set here This must match the board settings or no data blocks will be received any more Shown is the standard setting 32 Medlab GmbH MP01000 User Manual Regulatory Considerations The device that has been described in this document is not a final medical product This means that it cannot be used as a standalone unit to use it on patients Therefore the MP01000 has not been and also cannot be CE marked The customer has to undertake the procedure of CE marking with the final product that contains the module CE marking a multiparameter device is a serious task that is complicated and needs time and money The MP01000 helps the customer to develop a product that conforms to the standards in a faster way However it is up to the customer to test the final product to prove to the authorities and notified body that his product is in conformance with all the requirements 33 Medlab GmbH DocumentRevisions V0 95 27 11 2013 V0 96 03 12 2013 V0 97 20 12 2013 Initial Revision corrected typos corrected typos MP01000 User Manual 34 Medlab GmbH MP01000 User Manual 35 Medlab medizinische Diagnose
36. se only Byte 4 8 bit value internal use only Byte 5 8 bit value command lost host sent two consecutive commands to fast Byte 6 8 bit value counts unknown commands frame and crc errors during reception GENERALSTAT blocks are sent once only after an MPS command has been sent by the host VERSION BLOCK 4 bytes long Byte 1 8 bit value version of multiparameter board firmware Byte 2 8 bit value version of ECG firmware Byte 3 8 bit value version of NIBP firmware Byte 4 8 bit value version of SpO2 firmware VERSION blocks are sent once only after an MPV command has been sent by the host SERNUM BLOCK 4 bytes long Byte 1 32 bit value serial number lowest byte Byte 2 32 bit value serial number byte 2 Byte 3 32 bit value serial number byte 3 Byte 4 32 bit value serial number highest byte SERNUM blocks are sent once only after an MPN command has been sent by the host 25 Medlab GmbH MP01000 User Manual Command Blocks The module can receive several commands that after successful reception and decoding are then executed by the module Allcommands are standard communication blocks with a data block length of three bytes The commands are acknowledged by the board with a standard block of data length 0 On the following pages the data blocks of the commands are described in more detail After the board receives the command block it checks the following 1 All bytes of the command block arrived within
37. ue for UART interface mode 30 Medlab GmbH MP01000 User Manual Board Setup The board can store several user settings in its on board EEPROM These are programmed into the MP01000 using a special software provided by Medlab This program does not need installation just copy it to a directory of your choice and run it It requires MS NET 2 0 Connection to the MP01000 for setting these parameters is always done over the UART interface also if currently the main board communication is set to CAN interface In order to enter this mode power down the board and connect pin 5 and pin 6 of connector X4 see page 6 with a jumper If you now power on the board you are able to program the following settings UART mode or CAN mode UART mode is default on delivery Bit rate of the CAN mode 250 kBit 500 kBit or 1000 kBit ignored in UART mode Block identifier for ECG data blocks to the host default 0x100 Block identifier for other data blocks to the host default 0x200 Block identifier for command blocks to the board default 0x300 BPo1000Prooranmee re Fie COM Port ECG identifier address 0x100 C UART Block identifier address 0x200 CAN Command identifier address 0x300 500kBit rl Defaults Program Please note that programming is only possible if pin 5 and pin 6 of X4 are shorted during power up This is mainly to avoid unintended reprogramming of the parameters during normal operation Default button s
38. ware update System ground System ground R wave hardware trigger R wave hardware trigger Medlab GmbH MP01000 User Manual X3 Power Connector 1 VCC 7 15VDC Power supply of the board 2 Power Down Connect to GND to power down the complete board 3 GND System ground X4 Temperature transducer Connector 1 CH1 YSI400 probe 1 2 IGND Patientground 3 CH2 YSI400 probe 2 4 IGND Patientground 5 IGND Patientground 6 ISet Enables EEPROM programming when shorted to IGND Probe1 is connected to IGND and CH1 pin probe 2 to IGND and CH2 pin ISet is left open during normal operation X5 SPO2 Probe Connector 1 PH1 Photodiode positive input probe pin DSUB pin 5 2 PH2 Photodiode negative input probe pin DSUB pin 9 3 RSEN RSEN pin of probe DSUB pin 1 4 IGND Shield of probe cable Patient ground DSUB pin 6 and 7 5 LED1 LED1 pin of probe DSUB pin 3 6 LED2 LED2 pin of probe DSUB pin 2 7 PDAT PDAT pin of probe DSUB pin 4 The SpO probe has a male Dsub 9 connector The pin numbering for connecting the probe to the board can be found in the table above The internal connecting cable between probe and SpO connector should be kept as short as possible Depending on the RF immunity level your final product needs to fulfil 3V m or 20V m it might be necessary to include further EMC filtering measures close to the SpO connector input of your medical device Please contact Medlab for details X6 ECG cable Connector 1 C IN
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