User Manual
Contents
1. 8 Interface COnmeCtor secs e 8 Software Interface of the blood pressure PArt scssssescsssscsssecessccccsscsssccsssecscssssscsccsssesscssssesssssesssesssseeseesees 9 Explanation Of Terms Sss 9 General Conventions oe esise osser EE REPRE o LUN eR SEHE PE RE NUR R ERES VENUE EEES EUR Ra soosesudsvencosssuavcbesecoussdenessvenssuesesuad 9 legum m 9 Protocol Direction from Host to Slave eere eee ee eee eerte seen eerte seen nne tn netus etta setas sess etna senes etna sena 9 General COMV MUONS sissies sssscosncissceseuussscvecsencsancesesesesvesesaseesdoedestssooessanse Eo eE SEED ra ee PE Ce kw cb VR EL RENE PS des cbesdsascdsecesesteseuses 9 COMMAS eee 10 iuri cm M 11 ADORE enulI pee 11 Timing and Error Correction 4 eres e eese eee eese enses tns tn notant ta stessa tassa sens ense sane sa sossa tassa seta snn 11 Direction from Slave NIBP2010 to Host ecce esee esee eene eene eite nete neenon netu n aso sss sissies stoo sese sns tns sse tn se enaue 12 General Conventions 12 Initialization Message M 12 Cult Pressure TranSMiiSsiOMs scis2. pulse wave SpO pulse rate information quality gain Note The commands for pulse wave and information are active as long as no other command is sent Pulse Wave After the command byte OxF8 the pulse wave is sent by 7 data bits ranging from 0 to 127 and representing the amplitude of the plethysmogram curve The pulse wave is sent as the inverse plethysmogram curve ENVITEC Way ahead in technology Information The information is followed by one of the following bytes STATUS OK after removing failures SENSOR_OFF probe disconnected FINGER OFF no finger in the probe SIGNAL LOW no analysis possible i e very low perfusion or strong motion artefacts 1f no pulse is available weak signal alarm is provided after 15 seconds Pulse Detected proper pulse wave is detected optional S code number sent as soon as the module is connected to power followed by an 18 bytes long code number E error code Followed by 3 bytes OxOD 0x0A is an error code The following error codes may occur wrong EPROM checksum RAM cell error RAM address error Code number code number device not present code number CRC error current device is not a code device wrong code number red LED defective infrared LED defective photo diode defective both LED s or photo diode defective The status OK is sent after removing failures ENVITEC Way ahead in technology If a particular situation occurs the
3. all characters in inverted commas for command code 02 lt STX gt o 2 n man D g lt ETX gt OxF2 0x30 0x32 Ox3B 0x3B 0x44 0x38 OxF3 this frame corresponds to the following Hex characters Command Code Reserve Start measuring Reserve Select manual measuring mode Cycle mode minute Select manometer mode Start reboot ENVITEC Way ahead in technology Leakage test Request data from slave Set start pressure to 100mmHg only neonatal Set start pressure to 120mmHg only neonatal Set start pressure to 140mmHg only adult Set start pressure to 160mmHg only adult Set start pressure to 180mmHg only adult Select adult measuring mode Select neonatal measuring mode Continuous mode Version number EPROM NIBP2010 Extended mode Remarks e Commands 19 20 22 23 are ignored if not appearing in the corresponding measuring mode adult neonatal e During measuring or leakage test or during the manometer mode all commands are ignored Exception Abort Command ASCII X see Abort Command e Should the measuring unit receive command code 15 then a complete initialization is carried out Subsequently the measuring unit assumes the mode as described in the paragraph regarding the Abort Command Abort Command Regardless of the operational mode the session can be terminated by sending the X character The measuring unit immediately reverts to the mode Standby The pneumatic system
4. 150 mmHg pDIA 5 110 mmHg pMAP 10 130 mmHg 3 mmHg minute 300 mmHg adult and 150 mmHg neonatal mode 330 mmHg adult and 165 mmHg neonatal mode RS232 TTL level 19200 baud hardware reset typical normal 25s max adults 90s max neonates 60s Pulse Oximetry part of NIBP2010 ChipOx O Saturation Range O Saturation Accuracy Pulse Rate Range Pulse Rate Accuracy Quality Range 0 100 SpO gt 85 4 1 5 75 lt SpO lt 85 2 0 50 96 lt SpO7 lt 75 3 0 30 250 bpm 2 10 low 0 high Response modes Alarms Transmission Digital Filter Temperature Humidity Isolation serial Interface ENVITEC Way ahead in technology sensitive normal stable adjustable by host system default normal sensor disconnected finger off signal low error messages All alarms are detected in the module and reported to the host via the communication link resolution saturation 1 Hz pulse rate 1 Hz quality signal 1 Hz pulse wave 100 Hz 50 60 Hz and 100 Hz neon light 0 45 C 0 90 without condensation input via opto coupler optional Transport and Storage Conditions Temperature range Relative humidity Atmospheric pressure Standards EN 60601 1 Al A2 EN 60601 1 2 EN 55011 Class B EN 60601 2 30 EN 1060 1 EN 1060 3 DIN 58130 40 C 70 C 10 100 no condensation 500 1060 mbar ENVITEC Wa
5. discharges Example lt STX gt X lt ETX gt Sending X also suffices pressing X during PC test Timing and Error Correction During all operational modes the excess pressure detection and system error detection are activated In the following cases the measuring unit reacts as under the item abort command ENVITEC Way ahead in technology Reception of e Mutilated frames e Erroneous checksum e Unknown command e Violation of timeout criterion e The period between two characters of a receive frame exceeds 10ms In the following cases a hardware reset or a reboot command is necessary e All errors in auto test mode and manometer mode in leakage test and after system errors Direction from Slave NIBP2010 to Host General Conventions There are three types of frames which in the different situations are generated by the slave e Cuff pressure transmission 5 times per second e End of cuff pressure transmission e Status transmission Depending on the operational status the status frame shows the version number or the error code in message code see under remarks of the various points Initialization Message On power up the slave always generates a status frame within a few seconds Immediately thereafter the host can initialize the slave Frame example boot ok lt STX gt S0 A0 C00 Mxx P 3R T AF lt ETX gt CR Remark Here Mxx represents the version information and not th
6. lt STX gt 999 lt ETX gt CR Status Transmission After booting the leakage test and the measurement it may be recognized from this frame whether it was a successfully or unsuccessfully completed action This is expressed in the error code field The status is displayed on request by host by pressing command code 18 Frame structure real ASCII in inverted commas all lines consecutive lt STX gt S a0 nm A bO s ENVITEC Way ahead in technology C c0 cl us M d0 d1 P e0 el e2 e3 e4 e5 e6 e7 e8 RI 0 1 9 5 T g0 gl g2 g3 S bu h0 h1 lt ETX gt CR Explanation STX Start of Text ETX End of Text CR carriage return a0 ASCII digit a0 0 auto test in progress only during booting a0 1 waiting for commands standby cycle counter stopped a0 2 error evaluation of error bits cycle counter stopped a0 3 measuring in progress a0 4 manometer mode a0 5 initialization reboot in progress a0 7 leakage test a0 8 reserve b0 ASCII digit for the operational mode b0 0 adult mode b0 1 neonatal mode c0 and cl 2 ASCII digits for cycle mode in minutes c0 cl 00 no cycle selected ENVITEC Way ahead in technology d0 and d1 2 ASCII digits for messages after booting the version number appears here d0 d1 00 uninterrupted operation d0 dl 02 auto test failed during initialization d0 d1 03 uninterrupted
7. lt STX gt and End of Text lt ETX gt gt The module sends every 10msec data from ChipOx see Software Interface of the ChipOx at page 17 This data flow can be interrupted by blood pressure frames at each time All NIBP2010 blood pressure frames come as a block between STX and ETX The blood pressure frames from slave to host are terminated by a carriage return CR ASCII 13 Checksum The checksum is achieved via a modulo 256 summation through all the previous characters of both checksum characters in the corresponding frame string The STX character is not included Protocol Direction from Host to Slave General Conventions The measuring unit is controlled by the host via command frames Should the slave receive unexpected commands these will be ignored In addition to this false or unknown commands as well as violations of the timeout criteria will abort the current session in progress All data and commands are verified via checksum ENVITEC Way ahead in technology Commands A command consists of an 8 ASCII character frame This includes a Start of Text and an End of Text character as well as 2 characters for the checksum Frame Schema stx jo cl bh dt EX STX Start of Text OxF2 c0 and cl command code 2 ASCII characters Range of values 0 99 and 2 times semicolon x0 and x1 checksum 2 ASCII characters ETX End of Text OxF3 Example NIBP2010
8. operation d0 dl 06 cuff fitted too loosely or not connected d0 d1 07 leakage including sudden occurrence d0 d1 08 faulty slow loss of pressure d0 d1 09 pulse not recognizable cuff incorrectly fitted d0 d1 10 measurement range exceeded physiological d0 d1 11 too strong movement artefact d0 dl 12 excess pressure in accordance with IEC limits d0 d1 13 pulse signal saturated too large d0 d1 14 leakage determined during leakage test d0 d1 15 system error in measuring unit e0 to e8 each 3 ASCII digits represent the values for pSystole pDiastole pMean All values not ascertainable are expressed in dashes f0 f1 f2 3 ASCII dummy characters for the heart rate g0 to g3 4 ASCII dummy characters for the period in seconds until the next measurement only cycle mode in seconds in the cycle mode If the cycle mode is not active blanks are displayed h0 and h1 ASCII digits for the checksum Example lt STX gt S1 A0 C03 M00 P125090080 R075 T0005 D2 lt ETX gt CR lt STX gt start of Text 0x02 S1 waiting for commands module is in the standby mode AO adult mode C03 cycle mode with 3 minutes M00 uninterrupted operation no errors 125 last pSystole 125mmHg 080 last pDiastole 830mmHg 090 last pSystole 90mmHg R075 last heart rate 75mmHg T0005 the next measurement begins in 5 seconds D2 checksum lt ETX gt end of Text 0x03 CR carriage return ENVITEC Way ahead in
9. response mode to sensitive Setting the response mode to normal Setting the response mode to stable Setting the plethysmogram curve ON OFF Requesting the software version Generating a hardware reset Generating a software reset Example Sending the bytes 0xFB 0 The ChipOx responds by the code 0xFB followed by 1 2 or 3 depending on the adjusted sensitivity mode 20
10. ENVITEC Way ahead in technology Non Invasive Blood Pressure OEM board NIBP 2010 with PULSE OXIMETRY Type Chipox EnviteC Wismar Alter Holzhaven 18 D 23966 Wismar Tel 49 3841 360 317 FAX 49 3841 360 222 www envitec com ENVITEC Way ahead in technology General M M M 3 Blood pressure part of NIBP2010 4 eeeeeeeeeee eee eese en setenta sten sts sistens tns senses sense suse tuse tease esses sens suus 3 Pulse Oximetry part of NIBP2010 ChipOX cessere eren ee eene eren eee n eerte ntn unen n stus seis setas sens se tna seno 3 Mechanical dimensions H 5 Technical Data Specifications BN G 5 Blood pressure part of NIBP2010 sssscsssssssssssscsssssccsssssssssssssssssnsssseesscssessssssscssessscnsscssscsecessnesssessecseeees 6 Pulse Oximetry part of NIBP2010 ChipOX e eeeeeee esee seen sense ense tnn snn tnn tn setas tane ta setas tastes ses sens ennu 6 Transport and Storage Conditions eee eee ee ee eee ee sees esee eee en ntn naso tn setas sense enne seta setas sse ta senses eese seta sessanta 7 Ay iD UC M 7 TUI SUIDA 8 Serial Transmission Ee
11. e error messages as in other operational modes Example M10 then means Version V1 0 Cuff Pressure Transmission This frame is permanently displayed during a current measuring Basic frame structure real ASCII in inverted commas lt STX gt d0 d1 d2 C c0 S a0 lt ETX gt CR Explanation of dummies STX Start of Text ENVITEC Way ahead in technology ETX End of Text CR carriage return d0 d1 d2 3 ASCII digits which represent the current cuff pressure measuring Leading zeros are transmitted The C aution bit cO is used during a current measuring for the display of the cuff and corresponding measuring mode c0 1 module recognized the neonatal cuff in adult operation c0 2 module recognized the adult cuff in neonatal operation c0 0 all other cases The S tatus bit a0 displays the current operational mode a0 3 measuring a0 4 manometer operation a0 7 leakage test Example lt STX gt 035C0S3 lt ETX gt CR lt STX gt start of Text 0x02 035 current cuff pressure 35 mmHg C0 correct cuff is connected S3 module is in the measuring mode lt ETX gt end of Text 0x03 CR carriage return End of Cuff Pressure Transmission This message is generated after the cuff pressure transmission has been completed and thus after the blood pressure has been measured The measuring unit then reverts to standby Frame structure real ASCII in inverted commas
12. information byte is transmitted followed by an information about the corresponding cause Example The probe is disconnected The bytes FB 01 will be sent After reconnecting the sensor the information OK is sent as FB 00 If no failure occurs then the information OK is not transmitted Quality The quality of the signal is defined as follows Values 0 to 10 0x00 up to 0x0a Meaning 0 pulse rate and SpO2 are stable quality high 10 pulse rate and SpO2 are instable quality low Gain The gain is followed by a second byte stating amplification factor of the pulse wave A gain information is sent as soon as the gain factor changes Example for a data stream OxF9 0x50 OxFA Ox AO OxFB 0x03 OxFC 0x0a OxF8 0x03 0x05 0x09 OxOf means OxF9 SpO2 OxFA Pulse rate OxA0 OxFB Information status 0x03 low signal OxFC Quality OxOa instable values OxF8 Pulse wave 5 9 0x03 0x05 0x09 The same Example for a data stream with blood pressure OxF9 0x50 OxFA lt STX gt d0 d1 d2 C c0 S a0 lt ETX gt CR 0xA0 OxFB 0x03 OxFC ENVITEC Way ahead in technology 0x0a OxF8 0x03 0x05 0x09 OxOf see also Cuff Pressure Transmission ChipOx Receive Protocol The ChipOx can receive commands for adjusting the response mode and selecting the pulse wave on off First the command byte OxFB has to be sent followed by one of the following bytes Examine the selected response mode Setting the
13. ments will be carried out so much as possible within 5 minutes e determination of the heart rate from the oscillations transferred by the cuff Pulse Oximetry part of NIBP2010 ChipOx e The ChipOx features pulse oximetry technology in a very small and low powered design e The board consists of a multilayer PCB with surface mounted components with a total size of 77 x 65 x 12 mm e The system architecture and signal processing electronics are based on the EnviteC s pulse oximeter units e A new enhanced split pulse wave algorithm with fuzzy logic control technology is integrated and provides high quality and best results e The ChipOx connects to transducers specified and provides oxygen saturation pulse rate quality signal pulse waveform and other output information via the serial digital interface ENVITEC Way ahead in technology The ChipOx operates on a split pulse wave algorithm Additional plausibility calculations provide exact measurements Depending on the application 3 different response modes are available sensitive normal and stable The sensitive mode provides best accuracy with sensitive artefact rejection To achieve very stable values the stable mode is offered During each mode fast changes of oxygen saturation and pulse rates will be detected and transmitted Every second current values of oxygen saturation and pulse rate will be transmitted for all response modes The ChipOx requires certain signal quality fo
14. r high accuracy Several criterias are implemented to detect the human pulse wave forms Signals which do not meet these criteria e g due to high motion artefacts provide a low detection quality For each measurement a quality signal is given to evaluate the measured oxygen saturation and pulse rate This quality reaches from 0 to 10 and indicates the degree of artefacts ENVITEC Way ahead in technology Mechanical dimensions Technical Data Specifications Mechanical data see board drawing Module dimensions 80 x 60 x max 25 mm 1 x w x h One 10 pin twin row plug for all connections Weight 107g Attachment four M2 5 screws in the corners of the PCB Operating voltage 5 VDC 4 8 V 7 0 V or 12 VDC 11 0 V 13 0 V Max operating current 750mA 5 V 500mA 12 V Temperature range 10 C 55 C Relative humidity 30 75 90 no condensation Atmospheric pressure 700 1060 mbar Operating mode non supervised continuous operation Blood pressure part of NIBP2010 Type of measurement Pressure range Measurement ranges for adults Measurement ranges for neonates The leakage rate of the system is Overpressure limits Shutdown and pressure release after exceeding first fault condition Interface to host computer Time required for BD measurement ENVITEC Way ahead in technology oscillometric 0 300 mmHg pSYS 25 280 mmHg pDIA 10 220 mmHg pMAP 15 260 mmHg pSYS 20
15. ressure and the ChipOx Blood pressure part of NIBP2010 e Software compatible to NIBP2000 e New power down modus and better suppression of artefacts e CE certification of the NIBP2010 Module e the NIBP2010 operates very reliably and extremely patient safe in the adult and neonatal mode dual safety circuits for pumps valves and pressure sensors e the accuracy and reproducibility of the measuring results is very good and has been demonstrated by extensive clinical tests o the uniformity of results in the neonatal mode is very high through calibration with arterial reference measurements clinical trials in the Charit hospital Berlin o in the adult mode accuracy was achieved through a large number of test candidates with comparative measurements over 80 test persons each with 6 readings parallel to sphygmomanometer evaluation e the measuring time patient involvement contact is short e the generated noise has been reduced to a minimum e the long life span of the valves and pumps employed has been achieved by using tried and tested parts e artefacts are already recognized during the measuring sequence and effect a further validation of the readings e automatic adjustment of the start pressure depending on data of a previous measuring e automatic measuring mode in which the repetition of measurements is controlled by a counter The user can select between various times of repetition e short term automatic mode in which measure
16. sieeisssecosvensoseesseseseovessoiscvencedenssasobsevendesecsssesss ovestedasosscaseessssosontnaseinessasecesbestes 12 End of Cutf Pressure TransmisSSIOD sissccsescesccsasssscssesisesosicenscvseccosesvenoe Soscaesunssesusesevasecous S AKSNES EEr o IS SSY 13 SCACUS TAN SMMISSIOM 5 scicscsssessesesesvasdesscssdoesuacesncsasuesesvescoancestosessess cosstunssoincssactsediesesausveds setees soossonacs secsdevesssbesies 13 Manometer Mode isis cucssssscencs sasescsonascunseseacenbesosonvenussvencs cease seccanbesi suasesuadvonoesas esvosssensssestseeneosseseavenos S soasvossoeauesd 16 OT E H n 16 Software Interface of the Chip x eerie nene nn no nennen eio un eto aa ie nane eR Ea neo e eua oe au SHE No Da ao CN ua ae e eee ue ta uuo SS 17 tar 1 17 ChipOX m nlBgquuc m 17 anteire 4 D M 17 PUES WV AVE a e E EE E E EENE 17 Informatio enen E RUM E eee eee 18 Quality iiit I HH RE ERO FREIER FECE E A A 19 CG EU eee nee ERP ETE 19 CHIPOX RECEIVE ProtOCOl vevsiessisacascsssssscsviavssesvescussssossvesess sosaesedasscesenaosscsseade soshesseseso dbesduuedsssssonnsdssossensssesessees 20 ENVITEC Way ahead in technology General This document describes and defines specifications for the NIBP2010 OEM Bloodp
17. technology Manometer mode For the manometer mode send the commands 1 lt STX gt 51 DC lt ETX gt 2 lt STX gt 14 DB lt ETX gt In the manometer mode the offset pressure is transmitted first Example offset for channel 1 70 steps and channel 2 75 steps Offset 0 70 Stufen Offset 1 75 Stufen lt CR gt Stufen means steps The offset pressure range should be between 50 and 90 After sending the Abort Command X the module sends the pressure of channel 1 and channel 2 Connect the pressure indicator and pump up to 300mmHg Example for 150mmHg lt CR gt 1 150 mmHg 2 150 mmHg Remark If pressing over 300mmHg the valves will be opened and the module sends the message E07 High pressure Leakage Test Wind a cuff around a solid body with a diameter of about 7 5cm and connect it with NIBP2010 Send the command for Leakage Test lt STX gt 17 DE lt ETX gt NIBP2010 inflates to 200mmHg and after 60 Seconds NIBP2010 sends the Status string M00 Leakage test ok or M14 Leakage not ok leakage in the system is gt 3mmHg 1 Minute ENVITEC Way ahead in technology Software Interface of the ChipOx General Every second a new pulse rate oxygen saturation and quality value is transmitted Pulse wave values 7 Bit 0 127 are sent with 100 Hz ChipOx Send Protocol Identification A command byte identifies the values The following command bytes are defined
18. y ahead in technology Hardware Interfaces Serial Transmission The normal connection to the board is done via serial asynchronous communication with a baudrate of 19200 baud The interface lines operate on TTL voltage levels 0 and 5 volts A bidirectional connection is necessary since parameters like cycle rate start of measuring also first have to be transmitted for the module to start measuring Interface Connector 24 s 19 o A Pin 1 Pin 2 Pin 3 Pin 4 Pin 5 Pin 6 Pin 8 Pin 9 Power supply Pump 5VDC or 12VDC Power supply Pump 5VDC or 12VDC Power supply Logic 5 VDC or 12VDC GND NC NC Reset TTL Logic High or Low changeable RxD TTL Logic Pin 10 TxD TTL Logic ENVITEC Way ahead in technology Software Interface of the blood pressure part Explanation of Terms ASCII Character Standard Frames Character strings which are exchanged as commands or messages between the computers Host The computer which controls the measuring unit Interface to the user Slave The measuring unit computer Cycle Mode The measuring unit starts automatic readings The user is free to select the readout intervals This mode is controlled solely by the host computer General Conventions All NIBP2010 commands and messages begin with a Start of Text character STX 0xF2 and close with an End of Text character ETX 0xF3 In this document the designation for Start of Text is
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