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1. tec renes 10 SeIVICB oh cine SE pe Eee eA Ie eI sion Ee 30 SOLO cte oae tea cen tote E 16 SCUINGS x tos tet o ener ente RIO Ede EXEC 16 frequency limitation eseeeeeees 19 Shield iater greet e e 12 signal processing methoden 4 signal oualitv neneeese nenene neeese nene resrernr nn rsnrenrrnrsneee nne 6 simulation device 30 ences 35 special features osneneneeeeeee senene eo sreeer teresen tr rsree tee 5 SpO value at 50 eei nh 29 SpO value computing Dower sseeeeeeeerereerrreerreens 6 standard delivery eee 31 standard settings eessssssssssees 20 Standarde eene nennen nnne 7 28 GE dE EE 14 Ee Te E lesan sGataedec conarausateabictesteeds 8 Fi 14 Sub D ioi eei aec emet hate eere ea Bede ci esed feiner 32 suitable housing ssssssseeee 10 System IC EINER TIU NI ERI 20 T technical datami teet etti 25 temperature creen re eee eee EEN 27 thermal outp t EE 8 transfer layer teret ettet ederet enne 13 Droublesbootinmg h neisa e iaoeiaiai 29 U UART interface curet itti rine n recurso 5 User data teneo cannes 15 user instructions ese em 31 V NIEWEN e He eiii 10 vital parameterS e 16 EE 6 W wavelength sssssssssseeeee 4 25 31 Page 38 of 38
2. They should be wired exactly parallel a short distance from each other They are to be kept away from electromagnetic noise sources e g caused by chopper type regulators They should be flanked around the outside by GND lines The same applies for any adapter cables from the host PCB to the sensor connection For lengths longer than 10 cm a shielded cable should be used The success of the measure can be checked To do this a finger sensor is to be preferably used which can be applied across the thumb for example this unfavorable application is intentional so as to get a small useful signal Via the communication protocol see Chap 5 1 2 4 dynamic disturbances can be measured with the identifier value OxOb and a sampling rate of min 10 Hz If successful the read off value should then fluctuate between 10 and 20 or less 4 3 3 EMC measures ChipOx itself is already provided with measures for better electromagnetic compatibility with ferrite in all sensor lines However the EMC always additionally depends on the further integration of the module For better EMC we recommend that the sensor lines be wired through ferrite The EMC measurements with ChipOx have been passed through ferrite of type WE7427221 from W rth Elektronik Despite the EMC measures taken on ChipOx itis a good idea to wire a 100 pF capacitor to GND at each sensor line The signal shield For devices lacking ground connections usually small bat
3. 14 mm 5 mm Ber rr Sg gt x THEE INN BU2 M UJ c SN 0419 ME0016 Zany asyr ALN LE w ox o EA lt bottom side of ChipOx top side of ChipOx serial number View of bottom side connector side of ChipOx scale ca 5 1 Connector to Connector to host board host board Component height approx 1 2 mm Component height approx 2 0 mm Connector to the host Connector to the host Se Component height approx 1 2 mm iad approx 3 7 mm Please make sure that ChipOx is installed in suitable housing so that the safety information Chap 2 measurement conditions Chap 3 and hygiene specifications Chap 9 4 are observed ChipOx is to be plugged in out plane parallel and without tilting when it s being mounted or dismounted We emphasize here again that ChipOx is vulnerable to ESD if it s not in its installed state 47 07 00330002 g Date of issue 2006 03 6 Page 10 of 38 User Manual ChipOx 4 2 ChipOx Pin Allocation Dimensions Connections Mounting Number Host side BU1 Sensor side BU2 1 3V3 Free do not contact 2 GND Shield 3 RESET SENSOR ID 4 1 0 0 TXD IN A 5 1 0 1 RXD IN K 6 l O 2 Adr AO 0 LED AIR 7 1 0 3 Adr AO 1 LED ART 8 I O 4 Adr AO 2 AIN O 9 O 5 AO Strobe AIN 1 10 l O INT AIN 2 11 Analog Out Do not contact 12 Do not contact Do not contact 13 Do not contact Do not
4. User Manual ChipOx O operating Da trameter nee 25 operating Temperature 25 29 operating voltage ssse mm 29 Operati eieae eee teet ere o eo iet etia OSI model oxygen saturation sssssssssseeeeeeeeee 4 P le ele TEE EN packet structure 20 0 2 ceececccceeeeeeeeseeeeceeeeeseeeeaeeeeeeeess 14 parameterization eee eeeeeeeeneeeeeeeeeeeeseneeeeeenaes 16 parasitic frequencies oe eect ceeeeeeeeeteeeeeeneeeeeenaees 6 LTE EE 9 Pin allocation ei de 11 pin configuration development Kit 36 plausibility check ee 6 Plethysmogr rm irren ie 6 power supply eiie eint teret eiae ae aa ed tapa 8 CHIPOx Ac antec eigen a Md 8 development Kit 37 OI le EE 9 pulsation strength ee ee eeeeeeeeeeeeeeeneeeeeeneeeeeenaees 6 pulse volume 2 retain rete e teri qnte ee ees 6 R reaction TIME 2 oer teet esegue Eden 6 real time E 18 r caliDFatiOn 5 irem ete etes 30 repai aiana EP 30 laee LEE eA AEE E S EEEE T es 16 reset coe ipu iE E 16 S safety information ssssssssssssssee 7 sampling rate iisi ii eioi eaaa 6 17 20 25 secure transmission method 13 sensitivity pulse frequency essssssseees 17 D SE Ee dieta tcn 17 Sensor cable eegene eer Lr e iet ica 31 AEA ee dee EN 47 07 00330002 g Date of issue 2006 03 6 Index approved teet e mte nir ie 8 connection allocaton 32 serial number
5. 2006 03 6 Page 27 of 38 User Manual ChipOx 8 Error Messages Troubleshooting ChipOx is designed for safe operation detects most error states and passes this information on to the serial interface ChipOx monitors its own program sequence and restarts the program if a program flow error occurs Error Messages Troubleshooting In principle all status reports and messages with error numbers for all disturbances are to be checked on the communication channel 13 Problem Possible cause Remedy No communication possible Serial interface lines exchanged Check and correct problem if necessary Baudrate incorrectly set Try 9600 Baud default setting Communication protocol incorrectly implemented Check and correct problem if necessary ChipOx refuses to measure Wrong sensor connected Check also by requesting status report and sensor type and use approved sensor System error Check status reports and messages on communication channel 13 try to correct and if unsuccessful contact the manufacturer s service representative ChipOx displays 0 values during measurement Operating voltage too high or too low Check also over ChipOx status report and correct if necessary Operating temperature too high or too low Check also over ChipOx status report and correct if necessary Disturbances due to electrical AC voltage Check also over ChipOx stat
6. User Manual ChipOx 6 Technical Data 6 1 Operating Parameters Technical Data Parameter Value range units Accuracy Comments min max 0 3 Power supply V vs GND 3 3 Tol 04 V Ripple lt 100mV ss linearly regulated Current consumption at 300Hz 12 25 Additionally depending on whether measurements S mA are being carried out or not and on the regulated at 75Hz sampling rate 12 16 LED current Allowed operating temperature 20 60 C See also Section 3 2 6 2 Pulse Oximetry Parameters Parameter Value range units Accuracy Comments min max Analog signal sampling rate 75 or 300 Hz Better than 100 ppm Sensor wavelengths 660 905 nm gt maximum temperature increase by 2 C at point Thermal output 0 20 mW of application SpO measurement 45 100 70 lt SpO lt 100 better than 2 accuracy see Chapter 7 Measurement dynamics for FAL SpO lt 70 not validated sensitive First reaction after ca 1 s final vale reached after ca 4 Measured at desaturation resaturation between normal First reaction after ca 2 96 and 84 SpO under favorable measurement final value reached after ca 8 s conditions The values can be extended by a bad stable First reaction after ca A pulsation strength or motion artifacts final value reached after ca 12 s r e e Measured at default settings The worse the First displayed value
7. 38 User Manual ChipOx Description 1 Description 1 1 Intended use ChipOx is a pulse oximeter module for the non invasive determination of the functional oxygen saturation in human arterial blood SpO and for measuring the pulse frequency ChipOx can be installed as an OEM module in medical products or other applications for humans The parameters for pulse oximetry are measured using the sensors listed under the accessories which contain two LEDs of different wavelengths and a photodiode The sensors depending on type are applied to various parts of the patient s body e g the finger The signals are measured with 300 Hz to efficiently suppress noise From these values the pulse oximetry parameters oxygen saturation SpO pulse frequency pulse wave and the quality of these signals are calculated using various digital filters novel signal processing methods and calibration curves which are then made available to various on line interfaces The patient benefit of ChipOx is the information obtained about the oxygen saturation of his arterial blood and his pulse frequency can help with his therapy ChipOx is intended for installation in devices of the following application areas taking safety instructions into account anesthesia pre und postoperative monitoring intensive care emergency medicine sleep medicine ambulance service pulmonology therapeutic exercises sports medicine subactute care centers home
8. 78 Info Gan 17 Software screen shot Quality 10096 The Development Kit is for testing ChipOx It offers the possibility to immediately put ChipOx into operation in connection with the associated PC software and to test it The Development Kit offers the option to accommodate ChipOx direct sensor connections an RS232 interface to be directly connected to a PC the possibility for analog outputs in continuous demultiplexed form to be made available a power supply of 7V to 16V PC software for visualization It can be downloaded from http de envitec biz download chipoxV2 4 zip The Development Kit with its standard connections actual size X7 Xt 47 07 00330002 g Date of issue 2006 03 6 Page 34 of 38 User Manual ChipOx Development Kit 12 2 Connection Configuration 12 2 1 Connectors to accommodate ChipOx ChipOx is accommodated over 2 plug connections X5 BU2 on ChipOx and X9 BU1 on ChipOx Plug Pin Signal Function X511 N C Not connected X512 SHIELD Sensor shield X513 SENSOR ID Sensor ID X514 IN A Anode of the sensor photodiode X515 IN K Cathode of the sensor photodiode X516 LED AIR Anode of the infrared LED X5 7 LED ART Anode of the red LED X518 AIN 0 Analog input AIN O with reference potential GND X519 AIN 1 nalog input AIN 1 with reference potential GND X51 10 AI
9. Page 17 of 38 User Manual ChipOx Operation Identifier Length of the data Value Description reply value range For For request replies setting 0x51 Real time data channel sending selected data in a block variable variable 1 Data format at setting 1 byte block interval in steps of 100 ms 0 off an byte channel 1 identifier 3 byte number of values per block 4 byte channel 2 identifier 5 byte number of values per block 2 bytes per channel 20 byte channel 10 identifier 21 byte no of values per block Identifiers of 0x01 to Ox1F are possible When less than 10 channels are transmitted only the set ones are taken into consideration When the real time data channel is configured all following bytes are discarded if Number of values per block is sent with O one time Due to the internal data processing not every combination of block intervals Bi and number of values per block NVpB lead to the desired result Example The channel 0x04 Plethysmogram should be transmitted at 32 Hz in one block to 1 s Bi 10 and NVpB 32 Due to rounding errors ChipOx calculates a sampling interval SI of 30 ms based on the internal processing frequency of 100 Hz which leads to an actual sampling frequency of 33 333 Hz instead of 32 Hz The 32 sampled values then lead to the block being sent already after 960 ms instead of after 1 s Correct sampling frequencies Sf are only reach
10. after application 3 6 s measurement conditions the less reliable the first displayed value Pulse frequency measurement 20 300 Bpm 1 bpm up to 2 of displayed value Measurement dynamics for FAL Beat to Beat 1096 VS Reaction after 1 7 s sensitive 33 VS First reaction after 1 5 final value after further 1 4 sensitive 10 VS First reaction after 4 7 Maximum values measured with sudden change of final value after further 1 4 S 40 to 200 bpm and vice versa The reaction depends on the difference variance of the beats among normal 10 VS First reaction after 1 7 themselves final value after further 1 6 s stable 1096 VS First reaction after 1 7 final value after further 1 8 s 3 r Measured at default settings The worse the First displayed value after application 5 8 s measurement conditions the less reliable the first displayed value i i 0 A signal quality of gt 90 is good below this the Signal quality 0 100 o SpO values and pulse frequency can be unreliable Plethysmogram 0 255 LSB gt 6 ppm LSB o The pulsation strength is low if the value is under Pulsation strength Perfusion 0 250 loo 10 and is sufficient if this value is 157 54 This is Alac lpc see Section 3 4 5 also displayed by the status flag on the communication channel 127 identifier 0x08 Ambient light suppression Up to 14 x the measurement signal ifi A The pulse oximetry signal is low if the signal Signal amplification 0 255 1 ampl
11. closest to the settings of the pulse oximeter manufacturer BCI The entry of ChipOx into the settings is pending 9 3 Technical Service 9 3 1 Repair service Modules needing repair should be sent to the following address EnviteC Wismar GmbH Alter Holzhafen 18 23966 Wismar Germany If the error message indicates a defective sensor please only send the defective sensor with the error message information 9 3 2 Implementation support We can help you with implementation if you send your request to EnviteC info envtec com 9 4 Hygiene ChipOx is to be kept free of contaminants such as dust grease smoke particles and dampness during and after installation Contaminants can negatively influence the measurement ChipOx can only be cleaned in its uninstalled state with a circuit board cleaner ChipOx should not be installed unless it is completely dry and then only with regard to the information in Chapter 4 Cleaning and disinfection instructions for the sensors can be found in the package inserts 9 5 Disposal ChipOx can be disposed of as electronic scrap Alternatively ChipOx can also be sent to the ENVITEC s Technical Service address see above 47 07 00330002 g Date of issue 2006 03 6 Page 29 of 38 User Manual ChipOx Scope of Delivery 10 Scope of Delivery 10 1 Standard Delivery Replacement Parts Article Order No Pen PP minii sim we ChipOx OEM module in standard high quality packaging 47 00 0
12. connection is configured according to the standard for data terminal equipment DTE without handshake lines Pin Signal Function 1 N C Not connected 2 RX IN RS232 RxD input 3 TX OUT RS232 TxD output 4 N C Not connected 5 GND Reference potential ground 6 N C Not connected 7 N C Not connected 8 N C Not connected 9 N C Not connected 12 2 4 Pin header connector The following connections are available for feeding and receiving certain signals Pin X4 XT X13 Analog input Digital I O Continuous analog signals Signals output signals 1 AGND SHIELD GND AGND SHIELD 2 AIN O O 0 TXD AOUT 0 3 AIN 1 1 0 1 RXD AOUT 1 4 AIN 2 I O 2 Addr AO 0 AOUT 2 5 I O 3 Addr AO 1 AOUT 3 6 l O 4 Addr AO 2 AOUT 4 7 O 5 AO Strobe AOUT 5 8 l O INT AOUT 6 9 AOUT 7 The Jumper X6 connects the signal I O 1 RXD with the RS232 interface The Jumper X8 selects the sensor ID on the sensor connection X11 between Pin 1 and Pin 8 12 2 5 Power supply The Development Kit can be supplied over two 4mm sockets The green LED indicates that the Development Kit is in operation Plug Connection Signal Function X1 UB Power supply 7V 16V X2 GND Power supply ground 12 2 6 Button The button S1 is a reset button for ChipOx S 47 07 00330002 g Date of issue 2006 03 6 Page 36 of 38 User Manual ChipOx 13 Index A E
13. ede ec dee deer eerie eren 29 9 32 Implementation Support ied eie e etna see cede estate Ree RR HR EEEE ar eden 29 9 4 luci pe 29 9 5 DiSpo0Ssal desee sevo seiten eoi uos eps e bobo E ee ERO eege 29 10 Scope OF Delivery C C 30 10 1 Standard Delivery Replacement Parts cscsssssscsscccsscssccsssceesssssesscsesscssssccesssseesscsseseeees 30 UE ACCESSOMIES di eerie etate tno eH eae etes raten re Se oe to ve eb Uo eoe eee E 30 10 2 1 ULB 30 10 2 2 ther Accessories os eter CAR IRA UI m UR MB 32 10 3 Customer specific Options 4 eeee eere serene eerte ee eene enne etta setas to sss t tasse ease tones tasses ease ena aae 33 11 EEN 33 12 Development KIUs ssecivascasravdedsabesabescvtessecwietencsssevisbocbeannsounssnubsvasbarseseiaaceusisneriscavundsesuiiousnbetende 34 IZA DeSCrIP GON sri veccies E M 34 12 2 Connection Configuration ssesssesssesssesssesssessecssoossocssocssocssocssoossoossoossoossoossoossoosssosssosssosssosssse 35 12 2 1 Connectors to accommodate Chip 35 12 2 2 Sensot Connectioti EE 35 12 2 3 RS232 COMMECHOMN uc s eoe irte e RR RI RR I ee RUE EOM HERE REED e CERE URS 36 12 2 4 Pin header conector aee ee eR Re exte e eo qa ue de DU RR EUR UE UE e edits 36 12 2 5 Power supply Aue sean utet Ce RE eae er E De E oon HERR Ie RR CU QUIE RUNS 36 12 2 6 jin MEM d 36 13 EE 37 47 07 00330002 g Date of issue 2006 03 6 Page 3 of
14. monitoring 1 2 Functional Principle of Pulse Oximetry The technique of pulse oximetry is based on two principles First the color of blood which depends on the oxygen saturation is determined using two wavelength ranges red and infrared spectrophotometry Second the amount of arterial blood in tissue and thus also the light absorption due to this blood changes during pulsation caused by the blood being pumped from the heart into the arteries plethysmography The color difference caused by oxygen saturation is due to the optical properties of the hemoglobin molecule or to be more specific the organic heme component Hemoglobin is responsible for transporting oxygen in blood through oxygenation O2Hb The oxygen is released again later i e the blood is deoxygenated oxygen saturation goes down and loses its red color accordingly This influences the absorption of red light more and that of infrared light less To determine the arterial oxygen saturation the pulsation of the arterial blood flow is used The blood volume changes during the systole and diastole which has an effect on the light absorption Since only the change in light absorption is evaluated the non pulsating absorbing matter such as tissue bone and venous blood conditionally see Section 3 4 5 has no effect on the measurement The light sources for this measurement are a red and an infrared LED and a photodiode acts as detector The pulse oximeter measures t
15. operation near MRI or NMR devices or x ray machines and may not be operated in such an environment If the Operating Parameters are exceeded or the measurement conditions are disregarded this can lead to faulty measurements and can lead to damage to ChipOx in an extreme case If the sensors are applied in the wrong place or if the wrong types of sensors are applied the measurements can be falsified Body parts may also be pinched off by the sensor cable or the skin could be torn by the finger clip sensor etc Only the sensors and accessories offered by EnviteC for ChipOx may be used Sensors and accessories must be in perfect condition If other sensors and accessories are used it could lead to malfunctions and problems with biocompatibility Taking medicine or other preparations which change blood color the administration of intravascular dyes such as methylene blue or indocyanine green etc or a high concentration of dysfunctional hemoglobin can drastically falsify the measurement results ChipOx is intended as a support for diagnosis and monitoring ChipOx may only be used for making a diagnosis in connection with other clinical signs and symptoms It is not allowed to make a clinical evaluation based only on ChipOx results If there should be any reason to doubt the exactness of the measurement then the vital functions of the patient should first be investigated with other means Afterwards the functionality of ChipOx shou
16. 033 aga x HE s Zeen ve HU UL nn C 5 A re ke FEES nei TIS HE In one package there can be up to 10 articles User instructions in German The current version is available on the internet under http de envitec biz download 47 07 00330001 a www pdf 47 07 00330001 User instructions in English The current version is available on the internet under http de envitec biz download 47 07 00330002 a www pdf 47 07 00330002 10 2 Accessories 10 2 1 SpO sensors The SpO sensors are transmission sensors and include two LEDs with the wavelengths 660 nm and 905 nm as well as a photodiode for this spectrum The sensors are detected individually by ChipOx to the best possible accuracy or measurement 10 2 1 5 Overview of cables and sensors ENVITEC sensors Item length plug Order No MiniMed F 3227 SpO finger clip sensor 120 cm MiniMed 90 F 3225 Sub D F 3226 MiniMed Small SpO ear sensor 120 cm MiniMed 90 Sub D MiniMed 2311 1 Disposable SpO sensor for adults 20 cm MiniMed 90 2311 1 Sub D 2310 1 MiniMed All purpose SpO Y sensor 120 cm MiniMed 90 Sub D MiniMed Small SpO finger clip sensor 120 cm MiniMed 90 Sub D ENVITEC sensor cable Item Connections Length Order No MiniMed MiniMed 120 cm X 3227 12 MiniMed MiniMed 240 cm X 3227 24 SESCH Sub D Sub D 120 cm X 3226 12 Sub D Sub D 240
17. ChipOx The serial UART protocol for ChipOx is divided into the communication layer and the transfer layer The transfer layer contains error detection and corresponds to the Data Link Layer of the OSI model Communication layer Transfer layer UART line 5 1 1 Transfer layer The transfer layer is an asynchronous bit serial packet oriented secure transmission method in which control and user information characters are transferred over the connecting lines The transfer layer establishes a full duplex communication transfer layer of a point to point connection preferably between PCBs It is meant for systems with several independent hardware components which communicate with each other The communication paths are short The transfer layer structure is kept as simple as possible to allow its implementation in devices with relatively low computing power It is a simple polling transfer protocol Data from the host to the client ChipOx and from client to host are grouped in packets The error protection does not allow errors to be corrected autonomously Due to the dynamic changes in the data and the corresponding packet lengths the packets are not acknowledged Because the communication layer of the client doesn t receive any information from the transfer layer if there s an error in the packet e g incorrect checksum and therefore doesn t reply to the host the communication layer of the host which lies above the transf
18. ENVITEC Way ahead in technology User Manual Digital Pulse Oximeter Module ChipOx EnviteC Wismar GmbH Tel 49 3841 360 1 Alter Holzhafen 18 Fax 49 3841 360 222 www envitec com D 23966 Wismar Germany Email info envitec com 47 07 00330002 g Date of issue 2006 03 6 All rights reserved User Manual ChipOx Contents Contents J GS ocariitoii oralio eai dva asses dias ke be Po OPEP tauns opo con pee vp PR Ud uid ge 4 1 1 Intended USC SEs 4 1 2 Functional Principle of Pulse Oximetry eee eeeee eee ee eese esses eene enne etn netta stone setas sesta s eenue 4 1 3 Special Features of ChipOx c sscsscsscsssssssssesssssessessessesscsscsesssessssussnssucsussucsnssessncsecsesseesesaeeseeecess 5 1 3 1 Warning and error reporting system eene eren ener entrent trennen niente nnne nnne 5 1 3 2 3 freely configurable analog inputs sss eren ener nnne nne 5 13 3 Multiplexed analog o tput rte edt re e ae Dd e eoe et eden edes 5 13 4 Senalinterface for data exchange sdlicet d n o P Ne uds 5 13 3 Otherdigital tuned Eed e e ete d e i ede ecc en te edes 5 Lage Signabquahty x oet ttt PEE E t B p des 6 13 7 2Plethiysmogt m ueste e ea etus bos eb otii eta bias 6 1 3 8 Flexible Artifact Leveling PATI 6 1 3 9 Adjustable sampling rate AE EA E N E E enne n nre 6 2 Safety LETT E 7 BANT Tu TRE ITO T 8 3 1 Powe
19. N 2 Analog input AIN 2 with reference potential GND X51 11 12 13 14 Service For service purposes only Don t connect X911 3V3 Power supply 3 3V X9 2 GND Power supply ground X913 RESET Reset I O low active x9 4 l O 0 TXD Digital output UART TXD X915 O 1 RXD Digital output UART RXD X9 6 O 2 Digital output Analog Signal MUX AO X917 1 0 3 Digital output Analog Signal MUX A1 X9 8 1 0 4 Digital output Analog Signal MUX A2 X9 9 1 0 5 Digital output Analog Signal MUX Hold Sample X9 10 1 O INT Digital input for free use X9 11 ANALOG OUT Multiplexed analog output vs GND X9 12 13 14 Service For service purposes only Don t connect 12 2 2 Sensor connection The sensor is either connected using the MiniMed plug connector X10 or the female SUB D 9 plug connector X11 not both at the same time Pin X10 Pin X11 Signal Function 1 1 8 SENSOR ID Sensor ID 2 3 LED ART Anode ofthe red LED 3 2 LED AIR Anode of the infrared LED 4 7 SHIELD Sensor shield 5 5 IN A Anode of sensor photodiode 6 9 IN_K Cathode of sensor photodiode In the standard case the sensor ID is on Pin 8 and is selected over a jumper connection on the pin header connector X8 from Pin 1 to Pin 2 The connection X8 Pin 2 to Pin 3 selects Pin 1 from X11 as SENSOR_ID 47 07 00330002 g Date of issue 2006 03 6 Page 35 of 38 User Manual ChipOx Development Kit 12 2 3 RS232 connection The male SUB D9
20. SpO pulse frequency signal quality and plethysmogram are output This results in the following output frequencies Plethysmogram 100 Hz SpO pulse frequency and signal quality each 33 333Hz Output timing of a single channel ch1 dT 40 Ous dV 61 9mV iT e i Tap 1 Signal at Pin Analog Ou Taar 2 Address Pins I O 2 1 O 4 Tag 3 Sample Pin I O 5 Tu 4 Hold Tw 5 remove analog voltage The following times are typical Taar Tan 8 US Tabt Taar 7US Tu Tabt 10 12us Tw Tu 10 12us Overall duration Tw Tan 35 40us 47 07 00330002 g Date of issue 2006 03 6 Page 23 of 38 User Manual ChipOx Operation 5 2 4 Calibration signal In order to compensate for offset amplification and linearity errors and therefore to get the most exact analog output result possible there is the option of having a calibration signal output The calibration signal alternately outputs the maximum and minimum values of the corresponding channel The standard option Output of the calibration signal on all channels 3 dL EN eee abs DEE Analog output The calibration signal s period after a reset can be changed over the serial interface see communication protocol in Section 5 1 2 2 A spontaneous calibration signal can also be output 47 07 00330002 g Date of issue 2006 03 6 Page 24 of 38
21. Value range Units Accuracy Comments min max Measurement of analog inputs 0 150 mV Maximum settable input voltage Sun 1200 2400 Resolution 12 Bit overall error 3 2 LSB Sampling rate 100 Hz better than 1 Measurement of chip core temp 25 80 C 3 C Digital I O s as input 0 8xV 0 2xV V for logical Hi Lo 5V tolerant Digital I O s as output high voltage V 0 1 V lou 10 uA port I O push pull V 0 7 V lou 3 mA port I O push pull Digital I O s as output low voltage 0 1 V lo 10 uA 0 6 V lo 8 5 mA RESET pin low active 0 8xV 0 2 x V V Input current Ins 60pAy 100nF 47 07 00330002 g Date of issue 2006 03 6 Page 26 of 38 User Manual ChipOx Calibration Parameter Value range Units Accuracy Comments min max Dimensions 31x 14x5 mm Weight ca 1 9 g 6 5 Standards In the design and validation of ChipOx the standards in the table below were observed if applicable whereby the remaining risk of any errors was reduced to a minimum Standard Regulations Content EG Guideline 93 42 EWG 1993 06 14 Medical products basic requirements MPG 2002 08 07 Medical product law DIN EN 60601 1 1990 Medical electrical devices A1 1993 A2 1995 General safety definitions DIN EN 865 1997 05 Pulse oximeter special requirements ISO WD2 9919 Medical Electrical Equipment Part 2 54 Particular IEC WD2 60601 2 54 2002 requirements for the
22. basic safety and essential performance of pulse oximeters for medical use DIN EN ISO 60601 1 2 2002 10 Electromagnetic compatibility DIN EN ISO 60601 1 4 2001 04 Programmable electrical medical systems DIN EN ISO 61000 4 2 2001 12 Immunity to static electricity DIN EN ISO 61000 4 3 2003 11 Immunity to HF EM fields DIN EN 1041 1998 04 Availability of information 7 Calibration Studies carried out by University of L beck Institute for Anesthesiology Institute for Medical Technology 7 1 Evaluation The evaluation complies with the definitions in ASTM F1415 as well as those in ISO WD2 9919 and IEC 60601 2 54 According to this standard the approved pulse oximetry sensors are calibrated and evaluated against dyshemoglobin free reference measurements which were determined from CO oximeter data and do not contain saturation components of the hemoglobin fractions SaCO and SaMet With these values the functional and fractional Os saturation are identical Using this method the reference data falsification caused by dysfunctional Hb fractions which occurs often with smokers is eliminated for the most part With this data ChipOx has been calibrated specifically to the sensor within the range of 7096 100 SpOs The accuracy for the approved sensors according to this standard are Accuracy between Precision between Bias between 1 5 and 2 0 1 5 and 2 0 0 05 and 0 2 47 07 00330002 g Date of issue
23. byte 0x3a For testing purposes any data package which originates within the transfer layer of ChipOx can be generated The data transmitter is responsible for the content and further use variable variable 0x41 Set Baud rate 0 Baud rate inquiry 24 2400 48 4800 96 9600 default 19 19200 38 38400 57 57600 115 115200 23 230400 1 byte 1 byte 0x42 Sensitivity for SpO SpO FAL NW 0 3 Oz inquiry of sensitivity for SpO2 1 sensitive 2 normal default 3 stable 1 byte 1 byte 0x43 Pulse frequency sensitivity PF FAL VU 0 5 O inquiry of the pulse frequency sensitivity 1 beat to beat with 10 VS 2 sensitive and 33 VS 3 sensitive and 10 VS 4 normal and 10 VS default 5 stable and 10 VS 1 byte 1 byte 0x44 Sampling rate effective from firmware version V1 02 0007 0 inquiry of the sampling rate 75 75 Hz 30 300 Hz default 1 Byte 1 Byte 0x45 12 bit measurement range analog channel 0 AIN 0 O inquiry of the12 bit measurement range 17 0 to150mV 2 0 to 300mV 3 0 to 600mV 4 0 to 1200mV 5 0 to 2400mvV default 1 byte 1 byte 0x46 Meas range analog channel 1 AIN 1 see analog channel 0 1 byte 1 byte 0x47 Meas range analog channel 2 AIN 2 see analog channel 0 1 byte 1 byte 47 07 00330002 g Date of issue 2006 03 6
24. cm X 3226 24 47 07 00330002 g Date of issue 2006 03 6 Page 30 of 38 User Manual ChipOx Scope of Delivery 10 2 1 6 Details Sensor connection allocation with 6 pole MiniMed plug MiniMed ChipOx BU2 Signal 1 3 SENSOR ID 2 7 LED ART 3 6 LED AIR 4 2 Sensor shield 5 4 IN A 6 5 IN K Front view Sensor connection allocation with 9 pole Sub D plug Front view D ChipOX BU2 Signal 7 Sensor shield LED AIR LED ART IN A SENSOR ID IN K 00 01 C N OD o gt O1 BIN OD Nh 47 07 00330002 g Date of issue 2006 03 6 Page 31 of 38 User Manual ChipOx Scope of Delivery Sensor selection Sensor type Finger Clip Small Ear Y Sensor Small Finger Disposable Picture i Recommended for use on patients with a weight of more than 20 kg more than 30 kg more than 20 kg more than 20 kg more than 30 kg F 3227 ES 3227 Y 3227 FS 3227 2311 1 F 3225 ES 3225 Y 3225 FS 3225 2311 1 F 3226 ES 3226 Y 3226 FS 3226 2310 1 10 2 2 Other accessories Picture Article Best No Development Kit 47 00 0034 ChipOx introduction kit consisting of development board ChipOx fingerclip sensor F 3226 serial interface cable User instructions In Chapter 12 Development Board 47 00 0050 The circuit board from the Developmen
25. contact 14 Do not contact Do not contact 4 3 PCB Layout Recommendation 4 3 1 Footprint The plug connections are asymmetrically arranged along the longitudinal axis so that it is mechanically impossible to plug them in incorrectly when relatively high components are placed in the direct vicinity of ChipOx in a way that they prevent incorrect plugging We recommend that the counterparts to the connectors of ChipOx included in the accessories Chap 10 2 2 be used This includes the following layout recommendation dimensions in mm The datasheet to the counterparts should be observed in any case 23 6 ERO un eos Pis z 4 ZZ DO Br Dmm ho J Ede es Ze SEN scale 2 1 SS O E ChipOx is to be secured against falling out of the plug contacts by an additional fixture 47 07 00330002 g Date of issue 2006 03 6 Page 11 of 38 User Manual ChipOx Dimensions Connections Mounting 4 3 2 Special line wiring The electric wiring of the two sensor lines IN_A and IN_K require special care since the currents in these lines are processed in the nA range with a resolution up to the pA range via a differential amplifier Disturbances due to inductive coupling on these lines have a direct effect on the measurement quality For this reason the following applies for these lines They should be kept as short as possible up to the sensor connection
26. data from ChipOx Data channel ID 127 Identifier Data The identifier is used to allocate the data within the data channel 127 to a task For commands from the host to ChipOx regarding data requests or parameterization request setting the identifier is linked with the attribute 0x80 OR Afterwards further bytes will follow the identifier accordingly For messages from ChipOx to the host reply the identifier doesn t come with an attribute and the corresponding information comes in the following bytes Identifier Length of the data Value Description reply value range For For request replies setting Vital parameters 0x01 SpO value 0 100 1 byte 1 byte 9 0x02 Pulse 0 300 bpm 2 bytes 1 byte 79 0x03 Signal quality 0 100 more about this in Section 1 3 6 1 byte 1 byte 7 0x04 Plethysmogram 0 255 resolution max 100 Hz 1 byte 1 byte 79 0x05 Pulsation strength perfusion Alac lpc in 0 255 1000 1 byte 1 byte 79 0x08 Status Information 2 bytes 1 byte E Bit 0 Sensor is off Bit 1 Finger is out Bit 2 Pulse wave detected Bit 3 Searching for pulse Bit 4 Pulse search takes too long pulse can t be found within 15 s Bit 5 Low pulsation strength low AC DC ratio Bit 6 Low signal low AC and low DC signals Bit 7 Too much ambient light Bit 8 Too many disturbanc
27. ding to EN 61000 4 3 has been pretested ChipOx is not suitable for operation near MRI NMR or x ray machines ChipOx monitors disturbances in the measurement signal ChipOx cuts down measurement and sends a message if it detects that the signal is outside of the limits which allow low error measurement 3 4 2 Ambient light A normal amount of ambient light on the sensor can be compensated by ChipOx Strong or fluctuating ambient tlight e g direct sunlight or OR lamps can falsify measurements ChipOx monitors the ambient light ChipOx cuts down measurement and sends a message if it detects that the ambient light is outside of the limits which allow low error measurement 3 4 3 Motion artifacts ChipOx checks for motion artifacts and suppresses them for the most part with various algorithms and indicates when they get too high Still false data due to motion artifacts can t be ruled out especially ones of long duration 3 4 4 Dysfunctional hemoglobin intravascular dyes If the concentration of dysfunctional hemoglobin e g carboxyhemoglobin or methemoglobin which can t transport oxygen is too high the measurement can indicate a normal result although the patient is hypoxic since less hemoglobin is available to transport oxygen In such cases a pulse oximeter which uses two wavelengths to measure the functional oxygen saturation like ChipOx cannot be used Intravascular dyes such as methylene blue indocyanine gr
28. ed by selecting Bi and NVpB so that the following relationships are valid whereby the units for Sf Si and Bi refer to the following exemplary table Si 100 When Si is an integer then Sf Si e Bi n If n as an integer is chosen so that Bi 10 becomes an integer then NVpB Sf Bi 10 Exemplary table Sf Hz Si 10ms Bias steps of 100ms NVpB 100 1 1 2 3 4 10 20 30 40 50 2 1 2 3 4 5 10 15 20 33 333 3 3 6 9 12 10 20 30 40 25 4 2 4 6 8 5 10 15 20 20 5 1 2 3 4 2 4 6 8 10 10 1 2 3 4 1 SE ER 5 20 2 4 6 8 1 2 3 4 2 50 5 10 15 1 2 3 1 25 80 8 16 24 1 2 3 1 100 10 20 30 1 2 3 Bi is in one block of parameters when several channels of different sampling frequencies are transmitted which must be selected the same for all channels Data format in replies max of 130 bytes per data packet max 200 bytes per s Values for channel 1 values for channel 2 Example see Section 5 1 2 4 Standard settings 47 07 00330002 g Date of issue 2006 03 6 Page 18 of 38 User Manual ChipOx Operation Identifier Length of the data Value Description reply value range For For request replies setting 0x52 Real time data format as by 0 bytes Delivers current data format the way it has been set by OxD1 OxD1 0x61 Configuration of the m
29. een or other dyes falsify the measurement dramatically 3 4 5 Pulsation strength perfusion Sufficient pulsation is essential for a good measurement In many cases the term perfusion is used misleadingly By perfusion we understand the blood circulation whereat the flow of blood through the capillaries is meant The arterial pulsation for which a pulse oximeter is sensitive can be high whereas the perfusion is low simultaneously at contracted capillaries The vice versa case is cogitable likewise ChipOx measures the pulsation strength continuously as the photodiode current caused by the pulse wave AIAC IDC total pulse modulation and registers a weak pulsation when the pulsation is less than 196 which is usually the case e g when non prepared earlobe used as application place Then measurement falsification is to be expected The pulsation strength is negatively influenced by the use of blood pressure cuffs or arterial catheters arterial occlusion or if the sensor is applied too tightly Venous pulsation or defibrillation can also falsify the measurement 3 5 Connection of Free Inputs Please observe that if the voltage of external devices connected to the free analog or digital inputs is too low or too high see Section 6 4 this can lead to defects 47 07 00330002 g Date of issue 2006 03 6 Page 9 of 38 User Manual ChipOx Dimensions Connections Mounting 4 Dimensions Connections Mounting 4 1 Dimensions 31 mm
30. er layer must monitor the client reply time and if necessary resend the last packet The recommended monitoring time is usually 100 ms after which ChipOx should reply in any case Exceptions are the channels real time data format and the periodical response time on all channels whose reply is expected after the correspondingly configured time 100 ms The probability of a transmission error caused by the path can be estimated to be very low which justifies the lack of error correction Because data packets are sent without receiving an acknowledgement the addressee must always have its receiving equipment on Data packets not picked up by the addressee are lost 47 07 00330002 g Date of issue 2006 03 6 Page 13 of 38 User Manual ChipOx Operation 5 1 1 1 Hardware protocol of the transfer layer Serial UART interface variable Baud rate 1 start bit 8 data bits 1 stop bit no parity bits 5 1 1 2 Packet structure Every packet has the following structure Flag Data Checksum Flag Identifier Description Size Start flag Indicates the beginning of a packet Oxa8 1 byte Data Data packets variable Checksum_ Checksum as below from all characters in the field Data Send High byte first 2 bytes End flag Indicates the end of a packet Oxa8 1 byte The transfer layer divides its work into two layers The first layer conducts the data and the calculated checksum to the frame layer w
31. es Bit 9 Many motion artifacts Bit 10 Sensor defective Bit 11 Power supply outside of tolerance Bit 12 Operating temperature outside of tolerance Bit 13 Wrong sensor Bit 14 Vital parameter data outside of measurement range Bit 15 OxOb Dynamic disturbances e g fluorescent lamps EM interference fields 1 Byte 1 Byte 9 etc 0 255 Additional Measurements 0x11 Signal amplification 0 255 1 byte 1 byte 0x12 Analog input channel 1 0 4095 2 bytes 1 byte 79 0x13 Analog input channel 2 0 4095 2 bytes 1 byte 79 0x14 Analog input channel 3 0 4095 2 bytes 1 byte 79 0x15 I O port pins 1 byte 1 byte 9 0x16 Chip core temperature as signed int in 0 1 C steps 2 bytes 1 byte 79 Module Data 0x21 Firmware version IW Vx yy zzzz 17 bytes O bytes 0x23 Serial number 10 bytes 0 bytes 0x25 Sensor type variable 0 bytes Commands Settings 0x31 Reset hardware ChipOx reset pin is set to Low for 100 ms n a 0 bytes 0x32 Reset software ChipOx reset pin not influenced n a 0 bytes 47 07 00330002 g Date of issue 2006 03 6 Page 16 of 38 User Manual ChipOx Operation Identifier Length of the data Value Description reply value range For replies For request setting 0x33 Set idle mode for saving energy during time between measurements 0 wake up 1 sleep no measurements or messages 2 deep sleep wake up only possible over Low at reset pin 1 byte 1
32. evel a Host requests the pulse frequency from ChipOx with 127 0x82 0 For a pulse frequency of 168 ChipOx replies with 127 0x02 0x00 0xa8 Operation b Host requests the automatic transmission of the saturation every second from ChipOx 127 0x81 0x0a For a saturation of 9796 ChipOx replies automatically every second with 127 0x01 0x61 c Host requests the plethysmogram with 20 Hz and the pulse frequency with 1 Hz in the real time data channel whereby the real time data packet is sent every second by ChipOx 127 Oxd1 Ox0a 0x04 0x14 0x02 0x01 Reply from ChipOx automatically after every second for a pulse frequency of 100 127 0x51 20 Bytes for plethysmogram 0x00 0x64 Example answer a for calculating the checksum character by character Again the program sequence CS CS character CS Hi CS Hi CS Lo XOR character State Character CS Hi CS Lo Start 0x00 0x00 0x00 Character 1 Ox7f 0x00 OxTf Character 2 0x02 0x83 0x81 Character 3 0x00 0x04 0x81 Character 4 0xa8 0x86 0x29 Transfer layer level 16 bit operation In connection with the transfer layer the complete ChipOx data packet looks like Flag Data channel ID User data Checksum Flag Correspondingly on the hardware protocol level based on the transfer layer protocol the example a from above looks like physical data on transmission line Request Host
33. ffers 3 inputs for the measurement of other parameters which are each sampled with a maximum of 100 Hz and 12 Bits The sampling rate and the input voltage ranges are freely configurable over the communication protocol see Section 5 1 2 2 1 3 3 Multiplexed analog output ChipOx offers the option of outputting the vital parameters and other measurements as analog multiplexed signals on up to 8 channels ChipOx can then be either directly connected to a system with an AD converter or to a recorder over a demultiplexer 1 3 4 Serial interface for data exchange A serial UART interface is available as a digital output and for all settings which allows data to be exchanged over a secure protocol The standard protocol used here has a very versatile design so that most requirements are taken into account over a large selection of set parameters see Section 5 1 2 2 1 3 5 Other digital I O functions Most of the digital I O lines are occupied by the standard serial interface and the multiplexed analog output One of the pins I O INT is still free and can be used as an event input signal Its input is sampled with 100 Hz and can be polled over the communication protocol see Section 5 1 2 2 47 07 00330002 g Date of issue 2006 03 6 Page 5 of 38 User Manual ChipOx Description 1 3 6 Signal quality ChipOx supplies a value which represents the signal quality This is an index for the SpO value computing power ChipOx calculates
34. hat often host algorithm The repetition of a setting does not count as a setting change In other words if the setting doesn t change due to an identifier of 0x41 to OxGF this is detected by ChipOx Example An unfavorable algorithm would be for example when the host always resets the settings to ChipOx factory settings after every restart and then individually sets the response times of SpOz pulse and signal quality In this case this would correspond to 4 setting changes It would be better if these means were only taken if not yet done by ChipOx A change by ChipOx or a new ChipOx can be detected by means of the serial number 47 07 00330002 g Date of issue 2006 03 6 Page 19 of 38 User Manual ChipOx Operation 5 1 2 3 Communication data channel 13 System errors are transmitted on data channel 13 SYSTEM ERROR Telegrams on this channel are sent independently without request by ChipOx ChipOx does not accept any telegrams on this channel Data channel ID 13 32 bit error number high order first optional error text of variable length It is possible for ChipOx to announce the following system errors Number Meaning 20 or 3 RAM error ii Program memory checksum error 8 EEPROM Integrity faulty configuration faulty factory settings made 10 Code number faulty the code number is a kind of internal serial number 20 Serial interface parad
35. he ratio of red to infrared pulsating absorption which is directly proportional to the oxygen saturation In addition the time interval between pulsations is converted into the pulse frequency 47 07 00330002 g Date of issue 2006 03 6 Page 4 of 38 User Manual ChipOx Description 1 3 Special Features of ChipOx ChipOx has very small dimensions 31mm x 14mm x 5mm which allows it to be easily installed in medical products It also has low energy consumption is equipped with ESD and EMC protection and can be easily mounted on a carrier printed circuit board host PCB ChipOx also offers the following extra options and functions in addition to the pulse oximetric functions 1 3 1 Warning and error reporting system If the measurement and operating conditions aren t met then ChipOx reduces its measurement operation and sends a message see Section 5 1 2 if values are outside the limits which allow low error measurement In this way the user is requested to improve the measurement conditions The values determined under the measurement conditions for pulsation operating temperature and operating voltage are made available to the user as a check System errors e g sensor errors are also reported A loose connection can lead to false measurements or to the following error messages Vital parameters outside of measurement range Pulse search time out Motion artifacts 1 3 2 3 freely configurable analog inputs ChipOx o
36. hich is directly connected to the hardware UART Calculation of the 16 bit checksum from the Data block 0 is the starting value 8 bit character Example in C CS High Byte CS Low Byte wChecksum byChar HI BYTE wChecksum Hi C Lo LO BYTE wChecksum byChar T Example in Assembler for the uC 8051 MOV A byChar ADD A wChecksum 01H Low Byte MOV wChecksum 01H A Low Byte XRL A byChar ADDC A wChecksum Hi Byte CS High Byte CS Low Byte MOY MERC ke Una IDs The frame layer sends the packet consisting of data and a checksum between the start and end flag frame using a byte stuffing algorithm With this algorithm the addressee can detect the packets securely without losing the synchronization due to extraneous data traffic The reserved value 0xa8 is used for the start and end flags The second reserved character is the control byte with value 0xa9 If in the block data or checksum a character appears which is the same as one of the flags of the control byte it s coded with two bytes First the control byte is transmitted and the second byte is the original data byte AND linked with Oxdf byte stuffing 0xa8 is coded as Oxa9 0x88 Oxa9 is coded as 0xa9 0x89 The addressee can then clearly detect where one packet ends and the next one begins with the start and end flags If in the received data stream a control byte is detected it is to be ignored and the following byte is t
37. ification is over 160 This is also displayed by the status flag on the communication channel 127 identifier 0x08 FAL stands for Flexible Artifact Leveling For details see Section 1 3 8 Hl VS stands for Variance Suppression For details see Section 1 3 8 47 07 00330002 g Date of issue 2006 03 6 Page 25 of 38 User Manual ChipOx Technical Data 6 3 Analog Output Measured at V 3y3 3 3V over the entire temperature range Parameter typ value units Resolution 586 uV LSB Minimum output voltage 0 mV Maximum output voltage measurement range 1000 mV Maximum output voltage which can be applied at the 2400 mV analog output outside of sampling time Offset error max 30 mV Integral non linearity 1200 UV Differential non linearity 600 UV Amplification error max 50 mV Output resistance R4 at the pin Analog Out 22 kO Time until output voltage is reached with a accuracy of 10 US 1 2 LSBs Refresh cycle for all channels together except for 10 ms plethysmogram Refresh cycle for plethysmogram 10 ms Overall duration for the output of a channel max 40 us Calibration signal duration after reset can be deactivated 30 S Minimum period for calibration signal 1 S Maximum period for calibration signal 15 S Caution Voltages to the pin Analog Out must not be applied 6 4 Other Parameters Parameter
38. ing The signals are output multiplexed at the pin Analog Out Caution Voltages to the pin Analog Out must not be applied The signals are to be decoded over the output address at pins 1 02 to 1 04 and the pin I O 5 as sample hold controller The pins I O 2 to I O 5 are outputs and can t be influenced The function of this control has been tested with the sample hold device SMP08 from the manufacturer Analog Devices The allocation is as follows Analog channel 1 0 5 1 0 4 1 0 3 O 2 Addr AO Addr AO Addr AO 1 Addr AO 0 Strobe 2 No output 1 X X X 0 0 0 0 0 1 0 0 0 1 2 0 0 1 0 3 0 0 1 1 4 0 1 0 0 5 0 1 0 1 6 0 1 1 0 7 0 1 1 1 47 07 00330002 g Date of issue 2006 03 6 Page 22 of 38 User Manual ChipOx Operation 5 2 3 Timing The output frequency is 100Hz i e one channel is output every 10ms Therefore the output frequency per channel is divided into 100Hz number of activated channels If the plethysmogram is included among the activated analog channels then it is always output with 100Hz and additionally ca 200us later one of the other channels is output In this case the 100 Hz are distributed among all other channels Output of channels KO and K1 without plethysmogram KO JEL Output of channels KO and K1 and plethysmogram PI KO JUL JUL To Ti T4 To ca 200ys T2 To 10ms In the standard settings of ChipOx the channels
39. ing standards are to be taken into consideration by the user Any influences on or from the host system are not taken into consideration here rrr EE E E r E EE EE E These user instructions are a component of ChipOx Any action taken with ChipOx requires that the user is aware of the user instructions in all chapters and that they are observed ChipOx is only intended for the described purpose ChipOx as well as all accessories may only be used by persons with sufficient expertise ChipOx is delivered in high quality packaging Do not use ChipOx or the sensors used with it if one of the parts shows damage from transportation or other damage ChipOx is only to be integrated in a host system and operated by qualified personnel Before ChipOx is installed it isn t protected from ESD and has to be handled accordingly As part of a system the host must be electrically insulated from the patient according to EN 60601 1 and other regulations regarding electrical safety ChipOx is in no way insulated and all parts should be considered to be galvanically connected This is also true for the connected sensors The silicon layers on the LEDs and receiver do not qualify as insulation since they can be damaged if not used as intended ChipOx may not be submerged in liquids have liquids poured on it or be cleaned with liquid detergents ChipOx should also be protected from condensation and humidity ChipOx is not suitable for
40. ld be checked 47 07 00330002 g Date of issue 2006 03 6 Page 7 of 38 User Manual ChipOx Measurement Conditions 3 Measurement Conditions For successful ChipOx application please make sure you observe the following e safety information in Chapter 2 e operating and environmental conditions in this chapter and in Chapter 6 e ChipOx application and integration instructions in Chapter 4 and the connection between ChipOx and the sensor e interface specifications in Chapters 5 and 5 2 e the use of the approved sensors and accessories described in Section 10 2 1 and their correct application according to the included user instructions 3 1 Power Supply The power supply see Section 6 1 corresponds to the EN 60601 compatible low voltage supply medical safety extra low voltage MSELV Please observe that if the voltage is too high it can lead to defects We recommend a linear regulator be used to stabilize the power supply since a chopper type regulator can have a negative effect on the signal quality see Section 4 3 2 ChipOx monitors the power supplies If the power supplies are determined to be outside the limits which allow low error measurement ChipOx cuts down measurement operation and sends an error message ChipOx restarts its program if the power supply is briefly interrupted 3 2 Operating and Storage Temperature Humidity The following temperatures and humidity should be observed Ambient temperature H
41. ll 1 30 34 ambient light ertet ett enint 9 ambient Temperature 8 analog output enne 22 calibration sonal 24 Conftguration iieii iian 19 multiplexed sess 22 plethysmogram sseeee 23 technical data sssssssssssssss 27 analog outputs e enne seein ete 5 artifact leveling ioci tenentis 6 B Baud rate ie cere eee zen preda 17 blood pressure cuff nien nene 9 byte dest fflng eret teet ento ces 14 ELE ul Le WEE 14 C elle 28 calibration signal analog output eee ee eeneeeeeeeeeeeeneeeeeeaes 19 channel ID EN TE 16 ER 20 CHECKSUM 4 onere ee vier ie eee Ere 13 calculation 2 ettet cece 14 21 CICS ala rete 30 c mmandS ret eee te OTHER ceases 16 communication eese nme 13 communication Layer 13 15 computing Dower emn 6 e elle TC 11 contact address 0 ce eeeecccceeceeeeseeceeeeeseaaeeeeens 1 30 34 contaminants iisisti iieii idii emen 30 current Copsumpton 25 D WEI NEE 30 data channel ID 15 data JOSS e EET 13 data request E 16 decoding EE 22 defibrillation EE 9 desaturation during leen 6 e ln EE 14 development Kit 33 35 digital filter 5 nece cene 4 ell EE 10 disturbance signals eee 9 GV OS iecore te E aoe ete 9 E EMC pea E 9 ONO Le KEE ERIS 14 47 07 00330002 g Date of issue 2006 03 6 Index energy conser
42. o be linked with 0x20 OR destuffing 47 07 00330002 g Date of issue 2006 03 6 Page 14 of 38 User Manual ChipOx Operation 5 1 2 Communication layer The communication layer is one layer above the transfer layer and is completely contained in the data block of the transfer layer Transfer layer Flag Data Checksum Flag or Flag Data channel ID User Data Checksum Flag If the transfer layer of ChipOx receives faulty data packets this is reported to the communication layer which in turn sends the corresponding error message to the distant end 5 1 2 1 Structure of a communication data packet In order to be able to put the individual data packets together to form a block at the distant end or in order to be able to allocate the data packets to certain channels each packet consists of a data channel ID and the following user data Data channel ID User data N bytes The data channel ID defines the type of user data For ChipOx the following channels are used CHIPOX communication specific to ChipOx The user data are differentiated by the protocol using the data channel ID 47 07 00330002 g Date of issue 2006 03 6 Page 15 of 38 User Manual ChipOx Operation 5 1 2 2 Communication data channel 127 Most of the user data for ChipOx is transmitted on channel 127 CHIPOX The simplest procedure is the polling transmission where the host polls the individual
43. ommunication with C re E 13 54121 Pransfer layer zou oeste ib tbt isa ttti nf Eit iis ms 13 5 1 2 Communication layer ssesssssseseseeseeeeene enne nennen enn en rennen enne nre tenerte entren nene e nnne S rnea 15 SPEM D Cuin 21 5 2 Analog Output of ei re EE 22 52 1 Possible parameters esee de OmU nea epa dS 22 2522 Decoding 5 susnonovdav EDO Un B qt i ep sume t adis 22 523 ummng insouesevcednu eges eeu dle intet einip pte agnel ean bes 23 52 4 Calibration signal 4a nao EB OO deemed disp ais 24 6 Technical pio erc 25 6 1 Operating Parameters incccccessessesiscrasdccsseccenssovssscedsacecnseonsssovasosaadcecacesovesosadsecsscderssedesssossccseeacesses 25 47 07 00330002 g Date of issue 2006 03 6 Page 2 of 38 User Manual ChipOx Contents 6 2 Pulse Oximetry Parameters ccocccccsesoessvosvsssccscieeesvesvsesvevescounnecevasdossssosnacecaseovessosnascctecseeeseses 25 6 3 AMNAlLOT OAI IH a E 26 6 4 Other Parameters sies isccscesasesessss n 26 6 5 e EE EE 27 7 TE 27 7 1 JAETTA C mer 27 Error Messages Troubleshootin eegener 28 Maintenance STA QUIS RR 29 9 1 WIENIEC NI E TE 29 9 2 Jo neue qe H t 29 9 3 Technical ServiCe ec M 29 9 31 Repair Service ode eda R IRR PRETEREA RE eke side ee E
44. ox for exclusively serial data transmission 517 Ox Sensor Red LED defective 5207 Ox Sensor Infrared LED defective 537 Ox Sensor Photodiode defective 55 Ox Sensor Error can t be determined specifically 70 Stack overflow run time error ChipOx restarts 71 Watchdog reset ChipOx restarted due to run time error 7 f this error occurs ChipOx cannot continue to operate properly 5 1 2 4 Standard settings At delivery ChipOx standard operation is as if the following commands have been sent to ChipOx factory settings correspond to the execution of request identifier OXEF Parameter Description Request sequence Status information Sent any time there s a change 0x88 251 Baud rate 9600 Baud O0xC 1 96 SpO sensitivity normal 0xC2 2 Pulse frequency sensitivity normal and 10 variance suppression 0xC3 4 Analog sampling rate 300 Hz 0xC4 30 Range analog input channel 0 0 to 2400 mV 0xC5 5 Range analog input channel 1 0 to 2400 mV 0xC6 5 Range analog input channel 2 0 to 2400 mV OxC7 5 Real time data Every second SpO pulse frequency and OxD1 10 1 1 2 1 3 1 signal quality Analog output SpO pulse frequency signal quality and OxE1 1 2 3 4 plethysmogram Calibration at analog output Period after reset 10 s OxE2 255 10 47 07 00330002 g Date of issue 2006 03 6 Page 20 of 38 User Manual ChipOx 5 1 3 Examples Examples on the communication l
45. quency The lower the setting the faster the reaction when the pulse frequency changes The artifact stability however is weaker suitable for the measurement of HF variations for example The higher the setting the more stable the value but the longer the reaction time suitable i e for bumpy ambulance transportation In addition a plausibility check is installed for the pulse frequency measurement variance suppression VS in percent It evaluates the distance between two consecutive beats and considers the new value to be implausible as Soon as it deviates from the old value by more than the VS value plausibility control value At the same time the plausibility control value is adapted to the new value The standard setting Normal is a compromise between the two 1 3 9 Adjustable sampling rate To reduce the power consumption of ChipOx further more there is the facility to reduce the standard sampling rate of 300 Hz down to 75 Hz In this case it has to be considered that parasitic frequencies around 75 Hz can disturb the signal Frequencies lower than 61 Hz or higher than 91 Hz will still be suppressed effectively 47 07 00330002 g Date of issue 2006 03 6 Page 6 of 38 User Manual ChipOx Safety Information 2 Safety Information ChipOx was tested and qualified according to the standards listed in Chapter 6 5 insofar as these are applicable for an OEM module When being integrated in a host system all correspond
46. r Supply s Revo cosancacsenceesessonstascassestuceswasdssncesseesenntdssonesssoassessscecncs onbosccesscsenatevens 8 3 2 Operating and Storage Temperature Humidity eee eee crece eese eee eene en eerte nett nae 8 3 3 Sensors ANd BE NUUS TOS T RR 8 3 4 Factors Which Influence Measurement eee eee eee seen seen sets etta staat ta setas eta seta setas etna to se sns ano 9 3 4 1 Electromagnetic interference immunity EMC disturbance agnals sse 9 SAD Ambientlightes sso Rio het nao eniti 9 34 CMOLUODarttfaciss eterne epe D IN NINE MEE 9 3 4 4 Dysfunctional hemoglobin intravascular des 9 2345 Pulsation strength perfusion iet eren ier dente decret Pee Ee Hae ae deae e deed 9 3 5 Connection of Free INPuUts ccccccccoccsoscessncseiesssvsscocsaceesccsebsccsnessesasesesssssasooseccsesacesvansesnsoseeccensses 9 4 Dimensions Connections Mounting ssssssssssssssssssssesssocesoossoossoossssesssoossoossoosssossssesssoessoossooseos 10 4 1 RI 10 42 gt ChipOx Pin Allocation ette dees ainda cd tacit lee eee ee ean eects 11 4 3 PCB Layout Recommendation cccsscsssccccssccccccsscescssseecsccsescccsssccesssssessescescesssscesssssseseeseess 11 2 3 ee EE EE 11 432 Special line wars EE 12 ASS EMC measures eee EUN RU eb ER e Seiden a E CREE DR Re URL LIRE acs 12 4 3 4 Lines which are not standardly used nennen enne ener enne 12 AME OT n rr Pr PRI 13 5 1 C
47. rchase We don t make any guarantees when the user instructions weren t completely observed operating errors were made the device was handled or used in a way not intended non authorized personnel have manipulated the module forces of nature such as lightning etc transportation damage due to inexpert packaging when being returned operational and normal wear ENVITEC is not liable for consequential harm caused by a defect if it is not based on intention or gross negligence ENVITEC is also not liable for minor physical injury to life or limb resulting from negligence ENVITEC reserves the right to eliminate defects or faults to deliver a defect free product or to reduce the price as it so chooses If we reject the guarantee claim we will not shoulder the transportation costs The legal guarantee claims are not effected by this We recommend that our customers pass on the 2 year guarantee on to their customers D D D D D The guarantee conditions for the SpO sensors can be found in the package inserts included with delivery 47 07 00330002 g Date of issue 2006 03 6 Page 33 of 38 User Manual ChipOx Development Kit 12 Development Kit 12 1 Description SES Exit ChipOx Setup Help ENVITEC Way ahead in technology f N i N M 4 SpO2 i i Pulse bpm 98
48. t Kit Connector for connecting ChipOx with the host circuit board 47 000001 For 1 ChipOx 2 of these are needed Manufacturer Samtec Type FTM 107 03 L DV S Panel jack MiniMed 06 024193 For connecting the sensors with the MiniMed plug 47 07 00330002 g Date of issue 2006 03 6 Page 32 of 38 User Manual ChipOx Guarantee 10 3 Customer specific Options A serial UART interface is available as a digital data output and for all settings It allows data to be exchanged over a secure protocol Instead of the serial UART interface for data exchange and the multiplexed analog output which both have the standard set up I O lines can also be otherwise allocated Some possibilities would be other serial protocols SPI interfaces C bus interface For customer specific options please contact ENVITEC info envitec com 11 Guarantee ENVITEC does not guarantee the functionality of ChipOx if the owner or operator handles ChipOx ina manner not intended as described in these user instructions Please note that any guarantee claims become invalid if neither the recommended accessories in the user instructions are used nor the original replacement parts ENVITEC guarantees that ChipOx is free of defects or faults for a period of 24 months after the date of purchase if used as intended To make any guarantee claims it is required that you present the receipt of purchase which includes the vendor and the date of pu
49. tery operated ones There must be no AGND DGND GND from an external circuit connected to the signal shield but only to the shield of the sensor For devices with further cable bound interfaces such as a power supply or PC connection The shield connected to ChipOx is to be connected to GND in order to realize a large area ground connection with low NF and HF impedance from the input socket to ChipOx Furthermore it is to be made sure that the further circuit on the host PCB doesn t spread disturbances over the grounding surface since these can then be radiated over the sensor lines Furthermore it is to be made sure that no remarkable parasitic current can flow through this grounding surface e g from chopper type regulators or digital circuits 4 3 4 Lines which are not standardly used Non used lines are to be handled as follows The analog inputs AINO to AIN2 are to be wired over a resistance of 1 kOhm to GND The signal I O INT is an output lies at logical O and is to be left open The Signal RESET is to be left open or if used is to be coupled to an open collector or open drain circuit 47 07 00330002 g Date of issue 2006 03 6 Page 12 of 38 User Manual ChipOx Operation 5 Operation ChipOx has two interfaces available for operation aserial UART interface for communicating with ChipOx for setting parameters and for data output a multiplexed analog output for data output 5 1 Communication with
50. the SpO value not only once per pulse wave FPWA Full Pulse Wave Algorithm but several times the pulse wave is split up SPWA Splitted Pulse Wave Algorithm ChipOx splits the pulse wave as frequently as possible The SpO2 computing power splitting and SpO determination frequency per unit time depends on the signal quality The better the signal is high amplitude due to stronger pulsation fewer motion artifacts the higher the computing power and the associated output value is for the signal quality 1 3 7 Plethysmogram If possible ChipOx normalizes the plethysmogram which is output as a curve so that the amplitude makes up 75 96 of the display range This way it s independent of the pulse volume A signal proportional to the pulse volume can more likely be determined over the pulsation strength see Section 3 4 5 1 3 8 Flexible Artifact Leveling FAL Flexible artifact leveling FAL is used to suppress motion artifacts in the measurement of the SpO and pulse frequency parameters For SpO The lower the setting the faster the reaction is for desaturation The artifact stability is weaker however more suitable for desaturation during sleep The higher the setting the more stable the value but the reaction time is then longer suitable for restless jittery measurement conditions for example The setting should be chosen according to case The standard setting Normal is a compromise between the two For pulse fre
51. to ChipOx 0xa8 Ox7f 0x82 0x00 0x85 0x01 Oxa8 start flag CHIPOX Identifier for pulse date CS Hi CS Lo end flag Reply ChipOx to Host 0xa8 Ox7f 0x02 0x00 0xa9 0x88 0x86 0x29 0xa8 start flag CHIPOX Identifier for pulse HiByte LoByte byte stuffing CS Hi CS Lo end flag 47 07 00330002 g Date of issue 2006 03 6 Page 21 of 38 User Manual ChipOx Operation 5 2 Analog Output of ChipOx ChipOx offers up to 8 channels for outputting vital parameters and other measurements as analog multiplexed signals 5 2 1 Possible parameters The output range lies from 0 1000mV whereby the following channels have the resolutions indicated in the table below Parameter Range Resolution 1 SpO 0 100 10mV D se Pulse frequency 0 300 bpm 3 33mV bpm Signal quality 0 100 in 10 steps 100mv step Plethysmogram 0 255 3 9mV LSB Pulsation strength 125556 3 9mV ootpM Signal amplification 0 255 3 9mV LSB Analog input channel 1 0 4095 244uV LSB 7 Analog input channel 2 0 4095 244yuV LSB n Analog input channel 3 0 4095 244uV LSB Y Chip temperature 20 C 80 C 200 mV 10mV C 7 The highest resolution of the analog output is 590yuV LSB The output analog signals can be selected over a serial interface see communication protocol 5 2 2 Decod
52. ultiplexed analog output 0 7 configuration inquiry further bytes are ignored 1 byte per Configuration settings channel Channel 0 identifier up to OX1F Channel 1 identifier up to 1 byte per Ox1F channel Channel 6 identifier up to OX1F Channel 7 identifier up to Ox1F 255 turn off analog output default further bytes are ignored 0x62 Calibration signal at all multiplexed analog outputs 2 bytes 2 bytes The first byte refers to the current calibration signal The second byte refers to the calibration signal behavior after reset For both 0 inquiry 1 15 period in seconds and activate 255 calibration signal off Ox6F All settings are deleted and the factory settings described below are n a 1 byte made This is only done when the security byte OxF6 is transferred as a parameter ChipOx then carries out a software reset 0xB2 Error messages 0x71 Unknown data channel ID 2bytes n a 0x72 Unknown identifier 2bytes n a 0x73 Corrupt parameter 2bytes n a 0x74 Transfer protocol on receiving with number 1 byte n a 0x80 internal error 0x81 checksum error 0x82 overflow error 0x83 frame error 7 Data request The character after the identifier indicates the reply period in steps of 100 ms 9 The maximum value of the period is 250 which corresponds to 25 s The value 251 for the period is reserved for automatic transmission if change minimum time interval bet
53. umidity no condensation Storage between 30 C and 70 C between 0 90 Operation between 20 C and 60 C between 0 90 Operation or storage outside of these ranges implies improper handling ChipOx monitors the ambient temperature ChipOx cuts down measurement operation and sends a message if the temperature is determined to be outside the limits which allow low error measurement 3 3 Sensors and Accessories Please use only one of the approved sensors included in the accessories given in Section 10 2 1 and make sure it is applied correctly according to the included user instructions Make sure that neither the LEDs nor the detector in the sensor are dirty or wet ChipOx monitors the connected sensor ChipOx will not allow measurements to be made if a defective sensor or a non specified sensor is detected and informs the user of this The thermal output of the sensor is so low that no injuries are caused where it is applied Only one of those extension cords included in the specified accessories may be used Further extension cords could reduce the quality of the measurement results 47 07 00330002 g Date of issue 2006 03 6 Page 8 of 38 User Manual ChipOx Measurement Conditions 3 4 Factors Which Influence Measurement 3 4 1 Electromagnetic interference immunity EMC disturbance signals The compatibility with electromagnetic radiation according to EN 60601 1 2 and interference immunity accor
54. us report and shield if necessary Too much ambient light Check also over ChipOx status report and shield if necessary Error message Sensor off although sensor is still connected Wire SENS ID connected to wrong sensor pin Check against the sensor datasheet and correct if necessary Error message Photodiode is defective although the sensor is OK Photodiode wires exchanged Check and correct if necessary SpO gt value shows values around 5096 in the normal saturation range LED wires exchanged Check and correct if necessary Values at analog output too low Output load too high Insert impedance converter with high ohm input 47 07 00330002 g Date of issue 2006 03 6 Page 28 of 38 User Manual ChipOx Maintenance Service 9 Maintenance Service 9 1 Maintenance ChipOx maintenance or recalibration is not necessary 9 2 Function Check If ChipOx detects an error or non allowed states these are reported After installation ChipOx should be given a function check at least once a year or if malfunctioning is suspected A function test should be carried out with a finger sensor within the normal saturation range 95 to 98 SpO Alternatively a simulation device e g BIO TEK Index 2 or METRON deag can be used for the saturation range from 70 to 99 SpO and for a pulse frequency range from 45 bpm to 250 bpm The necessary settings for ChipOx are
55. vation cccccccceecceceeeeeeeeneeeeeeeeeeees 17 error Tags uae RM eee 16 messages seen etre Hoel eons 19 VEER ede e ien teen coa ens 20 event input signal eneeeeeeseesene ne eeeeee erns resreenr nr rereeee ne 5 le 21 EXTENSION CONG RE 8 F factory settings eee cee eeeeteeeeeeeeeeenneeeeeeas 19 20 FAL teg tere diane Maire Ed 6 flag QING WE 14 SUA E EE 14 frame layer 2 eee eere 14 free inputs innere eint 5 9 f nction check EE 30 functional principle of pulse oximetry 4 G g aranftee itte epe tee eget dedu 34 H hardware protocol sss 14 hemoglobin dysfunctional eeeee 9 il e EE E re ET 30 I Jet lie 5 l O Leitungen iere ded cei rei eene 12 lE EE 12 INE an Seed ER iet 12 installation oerte nente gererent 4 intended use ertet donee Ee Hu ERR Edu 4 L Ori e 11 limited measurement operation sssse 5 M MAINTENANCE ces icio tede ipee epi nee ces 30 ET de EE 30 measurement Conditions 5 8 measurement range of analog channel 17 MiniMed 2 reiecit ettet rerit eere 32 mod le datas oii deett eser ceat ces 16 motion artifacts eescssseseeeeee 6 9 us Te ue EEN 10 N noise suppression 0 ccceceeeeeeeeeee cece ee eeeeeaeeeeeeeeeeeees 4 Page 37 of 38
56. ween two messages is 100 ms for Status information pulse wave detected it can be less The value 252 turns off the periodical reply process z ne value 0 delivers the current measurement and has no influence on the periodical reply process For 16 bit values the high byte is sent first 3 Is automatically sent once after a reset Hl Both bytes correspond to the first 2 bytes of the received telegram After receiving the command ChipOx sends a reply in any case the contents of which is identical with the command itself This way QUE host can check whether the command was correctly understood H In order to avoid system overload the entire data rate for real time data and periodical reply processes is limited to an average of 250 bytes s Attempts to generate a data rate beyond this will be answered with the error value 0x73 faulty parameter FAL stands for Flexible Artifact Leveling More details can be found in Section 1 3 8 H VS stands for variance suppression More details can be found in Section 1 3 8 All setting changes identifiers 0x41 to Ox6F are permanently saved so that after ChipOXx is reset it works with the last made settings The number of setting changes is limited to a total of 10000 times If this is exceeded or if there was an error during saving ChipOx will bring out a system error message In this case it must be checked whether the settings really had to be changed t

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