sat 801
Contents
1. 16 SAT Sot CHECK ROUTINE 5 03i E RISE ANS Oo OR 17 7 1 PRELIMINARY REMARK anena 17 3 24 POWER SUPPLE CHECK 17 7 3 DEVICE SELF TEST AND BRIEF CHECK edes rt pent eee oU 17 J i PUA IVI LIVED TES CHECK nct tac st en Red al ee de 18 7 5 7 6 A 7 8 8 1 8 2 8 3 9 1 9 2 9 3 9 4 SEINNSOR ALARMS CHECK cinean a a aa 18 ACOUSTIC SIG NALS CHECK ROME Tho oe UN EE a a 19 DEVICE VALIDATION eren a a a 19 BRIEF CRECK e 19 SERVICE PROGRAM SERVICEBO retine Dort inen pede ede poe Rar 20 PRELIMINARY en oun aont no oa enn epe iia 20 GENERAL INFORMATION ABOUT THE SERVICES801 eee 20 PERFORMING A PARAMETER UPDATE coeno o eene een 21 PERFORMING A SOPTWARE JPDATE tiet iet eee ety equ HP HP quest hoec Pate Rees 21 DATA DOWNLOAD PROGRAM 8 23 PRELIMINARY REMARK t tot 23 GENERAL INFORMATION ABOUT 80 23 DOWNLOADING DATA uk tus t qiu en valen S vivet ed tee dta Dips eas edite ies 23 SETTING TIME AND DATE ctore aA 25 1 PRELIMINARY REMARK This technical information r2. 801 The welcome screen is displayed Turn on the sat 801 4 All stored parameters are displayed 21 6 Remove the USB cable from the sat 801 7 The sat 801 automatically switches off 22 9 DATA DOWNLOAD PROGRAM DOWNLOAD801 This chapter covers the following items e Using the Download801 program e Performing a data download 9 1 Preliminary remark Download801 program allows you to transmit stored monitoring data from the sat8o1 to a PC This data can be further analysed by an oximetry program such as TrendLibrary 9 2 General information about Download8o1 With Download8o1 you are able to e set and synchronize the system time of the sat 801 e perform a data download procedure 9 3 Downloading data 1 Setup the connection between the PC and the sat 801 2 Start Download8o1 3 Turn on the sat 801 4 Automatically the current sat 801 time setting S N and software version are transmitted to the PC and displayed 5 satB01 Communication e ll 30842 6 091734 rua 1308 AU 0211 5 Pliers 5 Click on Transmit to allow for the data download The data download starts m Commsnicatian Peine 12082006 048410 wm Se 10800012 wiii 11032006 04012 Wem 5 Tran Plime Towed dts 23 6 You will then be prompted for the target file 7 After successful storage of the file remove the USB cable from the sat 801 8 The sat 801 automat
3. display e Selection of pulse tone volume from 1 to e Pulse tone volume varies from very low 10 to very loud e Selection of pulse tone OFF e Pulse tone is switched off 7 Device validation This test requires the use of the pulse oximetry simulator SmartSat from Clinical Dynamics and cannot be carried out on a patient Additional test equipment Stop watch These tests are not part of standard service Contact the manufacturer for a detailed test description 7 8 Brief check A brief check is carried out by allowing the device to complete its self test 1 Connect the sat 801 to the public power supply via the plug in power pack 2 Switch the sat 801 on 3 Allow it to complete its self test 4 The brief check is completed successfully if the device reaches the monitoring mode without generating a system error 5 Switch the sat 801 off 19 8 SERVICE PROGRAM SERVICE801 This chapter covers the following items e Using the service program e Performing software updates 83 Preliminary remarks The service program allows you to read out modify and save again device constants parameters and settings stored in the sat 801 In addition it can be used to update the sat 801 firmware and the Masimo board software This requires a PC with a USB interface and an operating system W2k or later free memory space at least 10 Mbytes 8 2 General information about the Service8o1 The welcome screen appe
4. Sat 801 Pulse Oximetry System Technical Information and Service Manual Bitmos MEDIZINTECHNIK CONTENTS 3 4 PRELIMINARY REMARK ineo pn ie iei Rd RR RR REA 4 FUNCTION DESCRIPTION lt ac E cata td 5 2 1 INTENDED IJSE eU tende MEI 5 2 9 CONTRAINDICATION sesion tee eese 5 2 3 PRODUCT DESCRIPTION at 5 2 4 THEORY OF OPERATION ccs ELEN Ea ESE 6 TECHNICAL DESCRIPTION OF THE SAT 801 2 7 ASSEMBLY AO US GU oi tu pubs Mises qq 7 4 1 DISPLAYS AN DIC ONT ROIS AR 7 4 1 1 c ER tm ROM RN edes cte Lc 7 4 1 2 hres Con ends heed nal teed as ee vat deste ts galas ME 7 2 CONNECTIONS ON THE LINE aio enr a es ese epe 8 4 2 1 iicet matita eo susti Ehe D 8 i POWER SUPPE Mei ee dL NI CLE 9 4 4 BUTTON niet tenn ee ee Eee Hana ee 10 4 5 MASIMO BOARD A E 10 46 MICROPROCESSOR AND PERIPHERALS 5 entree nre 10 4 7 SELF DIAGNOSTIC CAPABILITY OF THE SAT 801 11 4 1 Watchdog and undervoltage 2222222 21 11 4 7 2 ies alu ln M MDC PLE 11 4973 RAM ehec 25 a 11 AA Clock module clie
5. ackage is sent by the Masimo board within 2 5 seconds a system alarm is triggered In addition the board mode the algorithm mode the averaging time and the set data format are checked for consistency once every second In the event of deviations a medium priority alarm is generated 11 If more than 5 transmission errors occur within 2 seconds or if incorrect board mode algorithm mode averaging time or data format information is detected more than 4 times a system alarm is also triggered 4 7 6 Operating voltage check Mains voltage check The battery voltage is measured at 0 5 second intervals and the measured value is averaged over a period of 10 seconds If the calculated average falls below a predefined 1 hour alarm threshold the 1 hour battery alarm low priority is generated If the calculated average value falls below the 15 minute alarm threshold the 15 minute battery alarm is generated If the average value falls below the U battery flat threshold a system alarm is generated If the average value falls below the U switch off threshold the device is switched off automatically Input voltage check The input voltage is measured at 0 5 second intervals If this voltage is below the specified threshold the current operating mode is recognized as battery mode The above mentioned battery voltage monitoring then applies 4 77 Loudspeaker check The loudspeaker is checked once after program start and then ea
6. ars after starting the sat 801 service program x tali Alem berets Acoustics Spi high Pulse Lora ssi SA S502 low onion a Mainboard SH Pulse hight Mapi 31 Masimoicerd S N Masmo uw 5 Ed tom or the satani In the left area you are able to e display and modify alarm limits for SpO2 and Pulse Rate e display and modify the SpO2 signal processing algorithm parameters such as averaging time and sensitivity e display and modify the acoustical settings e display and modify the access codes for clinical and home care mode 20 In the right area you are able to identify the serial numbers for the internal PCBs identify the firmware version perform a firmware update 8 3 Performing a parameter update 1 Setup the connection between the PC and the sat 801 2 Start Service8o1 The welcome screen is displayed 3 Turn on the sat 801 4 All stored parameters are displayed 5 Perform the necessary modifications in the masks 6 Click on the Transmit button to allow for parameter update of the sat8o1 2 amee PR diem ras neon POR Miele ii 4 M pcm E j ceo EE m mend iMd E rhii Paes fux Disma bureie LEE i 7 Remove the USB cable from the sat 801 8 The sat 801 automatically switches off a Performing a software update 1 Setup the connection between the PC and the sat 801 2 Start
7. ch time before an audio alarm is generated Two potential error conditions are detected short circuit and no contact If the check is not passed loudspeaker is faulty all audio signals are then issued via the buzzer If the error has been detected an additional low priority alarm is started 4 7 6 Stack monitoring The stack is continually monitored for overflow status If the stack pointer exceeds a pre defined limit a system alarm is generated 4 7 9 Detection ofan uncontrolled reset After the program start the system always checks whether or not the previous monitoring was completed as specified The monitoring status at the start of monitoring is stored in the NVRAM area of the clock module If monitoring was completed as specified the respective status is deleted If a respective monitoring status is detected after program start the system recognizes this as an uncontrolled reset A system alarm is triggered 5 MAINTENANCE PROCEDURES This chapter covers the following items e Regular maintenance procedures to be carried out on the sat 801 5 3 Preliminary remark The following sat 801 components are subject to wear e battery All other components are not subject to ageing 5 2 Battery replacement The manufacturer recommends replacing the Li battery at 10 year intervals Note Since the service philosophy is a complete replacement strategy the Lithium battery may only be changed in the ma
8. ckesci ua 11 4 7 5 Communication check with the Masimo board 11 4 7 6 12 4 7 7 Kouids peaker cocus cities aeta re o p op eb ru OR OR 12 479 Stack monitorning ssns nimi ing DR TOO OMIT did inp 12 4 7 9 Detection of an uncontrolled teset uiii ir bebe yt eie 12 5 250 14 PRELIMINARY REMARK csscsscsccsssesesccssesscscesssececssssseescesssesecearsusessessusesesesntneeseeseees 14 52 BATTERY REPLACEMENT 14 POSSIBLE ERRORS AND THEIR CORRECTION 15 6 1 ERROR SYSTEM ALARMS eene tes dise e dte dawns 15 6 1 1 Hardware related system alarms essere 15 6 2 ERROR GREEN AC POWER LEDS DO NOT COME 15 6 3 ERROR SAT 801 CANNOT BE SWITCHED ON IN BATTERY MODE 15 6 4 ERROR SAT 801 WILL NOT SWITCH ON IN MAINS MODE 15 6 5 ERROR YELLOW AND OR RED ALARM LEDS DO NOT COME ON 15 6 6 ERROR FAULTY LOUDSPEAKER estere nee XS TTA Re ABUS CUBES in Ve cs 16 6 7 ERROR DISPLAY VALUES NOT PLAUSIBLE AND OR
9. d values are not plausible or not within specification Error correction 1 Replacement of the sensor 2 Replacement of the patient cable 3 Hardware failure send unit in 16 7 SAT 801 CHECK ROUTINE This chapter covers the following items e Complete check routine for testing the sat 801 function 71 Preliminary remark All checks of this complete check routine can also be carried out individually The operability of the device however can only be assessed after completing the entire routine 72 Power supply check Action Result e Connection of plug in power pack to public power supply Green LED on plug in power pack comes on Connection of plug in power pack to the sat 801 e Green LED comes on 7 33 Device self test and brief check Action Result e Switching the device on using the ON OFF button e sat 801 performs several self tests in short succession e Watchdog test internal Undervoltage test internal Reset test internal e LC display test visual check for pixel errors e LED test visual check to find out whether or not both yellow and red LEDs are on e Loudspeaker test Acoustic check 7 4 Alarm limits check Note The upper and lower alarm limits must differ by at least 2 units Action Result Deletion of data memory Existing data are deleted Connection of a sensor for generation of p
10. e The battery voltage monitoring then applies The current battery voltage is measured at 0 125 second intervals averaged over 10 seconds and the resulting value is continually shown graphically on the display 4 4 ON OFF button When the ON OFF button is pressed the sat 801 is waked from the sleep mode 4 5 Masimo board The Masimo OEM board and the CPU communicate via a 9600 baud serial interface 4 6 and peripherals A microcontroller type ATMEL Atmega 329V controls the task sequence of the sat 801 It belongs to the AVR series and has an 8 bit core an internal in System Self Programmable 32 kByte flash EPROM an internal 2 kByte static RAM an internal 1 kByte EEPROM In addition the Atmega 329V has amongst other things an integrated 4 x 25 segment LCD driver 10 bit A D converter programmable Serial USART master slave SPI serial interface programmable watchdog timer with separate on chip oscillator an interrupt controller a 2 channel 8 bit timer a 16 bit timer and a real time counter with separate oscillator A real time clock module DS1374C is used to keep a real time and as a additional external watchdog timer with a directly buzzer control possibility The loudspeaker is controlled via a timer output pitch signal and a pulse width output volume signal This solution relieves the microcontroller from the task of direct waveform generation and ensures a good tone quality The louds
11. equires the knowledge of the sat801 Instructions for Use manual It is assumed that the operation and menu structure of the sat 801 are known In individual cases it is necessary to use the Instructions for Use manual together with this technical information 2 FUNCTION DESCRIPTION 2 Intended Use Continuous non invasive monitoring of the functional oxygen saturation of arterial hemoglobin SpO2 and the pulse rate measured by the SpO2 sensor in adults children and neonates for use in hospitals home care for mobile or stationary applications Monitoring may only be carried out with approved Masimo sensors 2 2 Contraindication Disposable SpO2 sensors of the Masimo LNOP series shall not be used in patients who show an allergic reaction to the adhesive tape The sensors must be removed and repositioned every 8 hours and as soon as indicated by insufficient blood circulation or other skin irritations Reusable sensors of the Masimo LNOP series shall not be used for long term applications These sensors are not suitable for long term monitoring They must be removed and repositioned every 4 hours and as soon as indicated by insufficient blood circulation or other skin irritations 2 3 Product description The sat 801 pulse oximetry system comprises the sat 801 pulse oximeter based on the Masimo SET technology a plug in power pack a patient cable and different disposable or reusable SpO2 sensors The sat 801 pulse oxi
12. hysiological signals SpO2 and pulse values are displayed after a short delay Adjusting the upper alarm limit for SpO2 to a value below the displayed SpO2 value SpO2 high alarm is triggered If possible Adjusting the lower alarm limit for SpO2 to a value above the displayed SpO2 value SpO2 low alarm is triggered Adjusting the upper alarm limit for pulse to a value below the displayed pulse value Pulse high alarm is triggered Adjusting the lower alarm limit to a value above the displayed pulse value Pulse low alarm is triggered 75 Sensor alarms check Action Result Switching on the device while the sensor is put on sat 801 changes to search mode then displays the current SpO2 and pulse rate values Disconnecting the sensor from the patient connecter while the sat 801 is operating Sensor alarm is triggered Reconnect sensor to sat 801 Alarm stops Remove sensor from finger Sensor alarm is triggered Reapply sensor on finger Alarm stops Slightly lift sensor off finger and direct light from a light source to sensor Sensor alarm is triggered 7 6 Acoustic signals check Action Result e Selection of alarm tone volume from 1 to e Alarm tone volume varies from very low 10 to very loud e Selection of alarm tone OFF e Alarm tone is switched off At the same time the symbol appears on the LC
13. ically switches off 24 9 4 Setting time and date 1 Setup the connection between the PC and the sat 801 2 Start Download801 3 Turn on the sat 801 4 Automatically the current sat 801 time S N and software version is transmitted to the PC and displayed aliti Communicalsmn tsa 5 Synchronize the PC time with the sat 801 time by clicking Transfer PC time 6 Remove the USB cable from the sat 801 7 The sat 801 automatically switches off 25
14. meter consists of a housing that is suitable for stationary e g hospital sleep laboratories home care and due to its small size and low weight also for mobile use inside and outside of health care facilities such as emergency and home care applications The sat 801 has a customized LC display for indication of numerical SpO2 and pulse values and the status of the unit Additional LED displays indicate the power supply and alarm status of the device Vital signs sensor status and system alarms are given visually and or acoustically Upper and lower alarm limits can be adjusted both for SpO2 and for pulse rate The unit is operated by means of four buttons The sat 801 is based on the Masimo MS 13 OEM board Communication with the device control hardware takes place at 9600 baud via a serial interface The sat 801 has an internal memory of 2 Mbytes for every second recording of at least 160 hours of SpO2 pulse rate and IQ monitoring The internal memory can be read out via the USB interface only The sat 801 is powered via an external plug in power pack with a wide range voltage input 2 4 Theory of operation The function principle of the sat 801 pulse oximeter with Masimo SET is based on the fact that oxyhemoglobin and desoxyhemoglobin differ in their capability of absorbing red and infrared light that the volume of arterial blood in the tissues varies from pulse to pulse thus also the light absorption by the blood and the arteri
15. nit 4 2 1 Block d agram The following block diagram describes the functional units of the sat 801 Main board usb Daten Super Power Buzzer Interface Flash Cap Supply Batterys Progr Reset Flash BES Monitor uc LCD SRAM EEPROM Controller Timers Masimo M board LED LED i yellow LED red green Film keyboard Loud LCD Display DC In Patient USB Speaker Jack connector connector Fig 1 sat 801 system overview All functions of the sat 801 are arranged on two printed circuit board Masimo MS 13 board pulse oximetry signal acquisition e Main board microprocessor with USB interface buzzer power supply and LCD 4 3 Power supply The sat 801 is either powered via an external plug in power pack 4 5 V or by two AA batteries e Euro version Egston NiEFM 12 W 4 5 V 1 96 The sat 801 works with two different internal operating voltages e DC 5 volts Masimo board DC 33 volts Main voltage A circuitry is available which protects the device against incorrect polarity and overvoltage No sufficient voltage is supplied if the input voltage is less than 4 0 volts The input voltage is measured at 0 125 second intervals If this voltage is below the specified threshold the device switches to battery mod
16. nufacturer s service department 6 POSSIBLE ERRORS AND THEIR CORRECTION This chapter covers the following items e Description of possible errors e Information about their causes and correction 6 1 Error System alarms 6 1 1 Hardware related system alarms All hardware related system alarms need to be serviced at the manufacturer 6 2 Error Green AC power LEDs do not come on Error situation Green AC power LEDs do not come on Error correction 1 Check function of plug in power supply 2 Hardware failure send unit in 6 3 Error sat 801 cannot be switched on in battery mode Error situation sat 801 cannot be switched on in battery mode Error correction 1 Replacement of the batteries 2 Hardware failure send unit in 6 4 Error sat 801 will not switch on in mains mode Error situation sat 801 will not switch on in mains mode Error correction 1 Check function of plug in power supply 2 Hardware failure send unit in 6 5 Error Yellow and or red alarm LEDs do not come on Error situation Yellow and or red alarm LEDs do not come on Error situation is confirmed by visual self test Error correction Hardware failure send unit in 15 6 6 Error Faulty loudspeaker Error situation Loudspeaker is not activated buzzer is activated instead of the loudspeaker Error correction 1 Hardware failure send unit in 6 7 Error Display values not plausible and or faulty Error situation The displaye
17. ovenous shunting is very variable and the fluctuating absorption by the venous blood is the dominant noise component Since oxyhemoglobin and desoxyhemoglobin absorption capabilities are different the amount of red and infrared light absorbed by the blood is related to the oxygen saturation of the hemoglobin Masimo SET divides the red and infrared pulsating portion of the absorption signal into an arterial and a noise signal thereby calculating the ratio of the arterial signals without the noise portion The ratio ofthe two arterial absorption values is used by an empirically derived equation in order to determine the oxygen saturation The values in a table are based on studies conducted with patients whose oxygen saturation values measured with Masimo SET technology were compared with the results obtained with an Co oximeter 3 TECHNICAL DESCRIPTION OF THE SAT 801 4 ASSEMBLY 4 1 Displays and controls 4 1 1 Front LCD Display Green latticed LED Yellow alarm LED Red alarm LED gt 5 Backlight button and Down arrow navigational button 6 Menu button 7 On Offbutton 8 Alarm mute button ied and Fig 1 Front Up arrow navigational button 4 1 2 Back 1 Loud speaker Battery compartment lock Battery compartment Fig 2 Back 4 2 Connections on the unit Connections on the upper panel of the unit 1 USB Interface 2 Patient cable connection 3 AC adapter socket Fig 3 Upper panel of u
18. peaker can be tested for short circuit and no contact error conditions If such a system occurs an additional buzzer will be activated 10 4 7 Self diagnostic capability of the sat 801 4 7 1 Watchdog and undervoltage reset To check the watchdog WDT function the WDT toggle signal is interrupted and the reset function is checked at undervoltage voltage divider simulates undervoltage after program start If these tests are not passed respective system alarms are generated 4 7 2 ROM check The internal flash program memory is checked upon initialization and at regular time intervals lt 10 h according to the CRC 16 method Ifthe ROM check is not passed a system alarm is generated 4 7 3 RAM check The whole internal RAM area is checked once before the major loop is started Ifthe RAM check is not passed the sat 801 is rebooted 4 7 4 Clock module check The data in the NVRAM are protected with CRC 16 After each device start from the power off status the data are loaded from the NVRAM and checked using the CRC 16 method If the CRC is not correct a system alarm is generated 4 7 5 Communication check with the Masimo board After power on and completion of the above mentioned internal self tests the Masimo board is supplied with voltage reset and initialized All data packages received by the Masimo board are constantly checked for start and stop bytes as well as for checksum If no new data p
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