901-M / 901-ML
Contents
1. A a 11 3 8 3 bise E 11 Clock module check aio RIS UR ineo 11 3 8 5 Communication check with the Masimo 11 3 8 6 12 3 8 7 Eoudspeaker check o adiecta be Ad ase Dante dita 12 ZBB LScloohiterigs Sins peut ou Man UL pet d 12 3 8 9 Detection of an uncontrolled FeSEE cec o rre oit eti e nee 12 4 MAINTENANCE PROCEDURES n oras eut ut deut eoa eu 14 41 irs 14 42 14 4 9 LIION BATTERY REPLACEMENT iiit tera to Ete 14 5 POSSIBLE ERRORS AND THEIR CORRECTION 16 5 1 ERROR SYSTEM ALARMS T tuac e bar 16 5 1 1 Hardware related system alarms essent 16 5 2 ERROR GREEN AC POWER LEDS DO NOT COME 16 5 3 ERROR 901 M 901 ML CANNOT BE SWITCHED ON IN BATTERY MODE 16 5 4 ERROR 901 M 901 ML WILL SWITCH MAINS MODE 16 5 5 ERROR YELLOW AND OR RED ALARM LEDS DO NOT COME ON 16 56 ERROR FAULT2. 12 The unit displays c1 hour 13 Set the correct year using the up and down c buttons 14 Press the menu button 15 The unit displays c2 minutes 16 Set the correct year using the up B and down c buttons 17 Press the menu button B 18 The unit displays c3 seconds 19 Set the correct year using the up B and down buttons 20 Press the menu button B 21 The 901 M 901 ML automatically switches off 27
3. 1 USB Interface 2 Patient cable connection 3 AC adapter socket 3 3 Block diagram Fig 3 Back 1 2 3 Fig 1 Upper panel of unit The following block diagram describes the functional units of the 901 M 901 ML Main board USB Super Power Alkaline 901 M Buzzer Interface i Figs Cap Supply Lilon 901 ML batteries Progr Reset Flash Monitor uC SRAM EEPROM LCD i Controller Timers Masimo MS13 board LED LED Film keyboard yellow red green Loud LCD Display DC In Patient USB speaker Jack connector connector Masimo 5 13 board pulse oximetry signal acquisition 901 M 901 ML system overview All functions of the 901 M 901 ML are arranged on two printed circuit board Main board microprocessor with USB interface buzzer power supply and LCD 3 4 internal batteries Power supply DC 5 0 volts Masimo board DC 3 3 volts Main voltage The 901 M 901 ML works with two different internal operating voltages The 901 M 901 ML is either powered via an external plug in power pack or by 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
4. 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 6 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 physiological signals SpO2 and pulse values are displayed after a short delay Adjusting the upper alarm limit for 5 2 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 6 5 Sensor alarms check Action Result Switching on the device while the sensor is put on 901 M 901 ML changes to search mode then displays the current SpO2 and pulse rate values Disconnecting the sensor from the patient connecter while the 901 M 901 ML is operating Sensor alarm is triggered Reconnect sensor to 901 M 901 ML Alarm stops Remove sensor f
5. me ge Je 2 901 Communication Acoustics E ij b ij Al suppr time 60s Alarm limits 5 02 high fo BP Masimo Averaging time 85 E Lo Pulse tone 5 02 low Alarm tone Pulse high Pulse low Sensitivity Transmit All stored parameters are displayed Mode Access code clinic 1968 Access code home 2606 Home Clinic C HomeCare Mode Clinic Mode Data mode werwrite C Freeze Setup the connection between the PC and the 901 M 901 ML Start Service901 The welcome screen is displayed 901 Parameters 03000000 071 011160242 45065449 901 S N Mainboard S N Masimo Board S N SW Version 4 02 Update 5 Click on the Update button to allow for a software update of the sat801 2 901 Communication Acoustics n ij Al suppr time 80s Alarm limits SpO2hign 0 je Masimo Averaging time 85 Lo 4 Pulse tone 5 02 low Alarm tone Pulse high Pulse low Sensitivity Transmit Mode Access code clinic 1966 Access code home 2606 Home Clinic C HomeCare Mode Clinic Mode Data mode werwrite C Freeze 901 Parameters 03000000 071 011160242 45065449 801 S N Mainboard S N Masimo Board S N SW Version 4 02 TEE RE E ERR ER EL ERE RE 6 Remove the USB cable from the 901
6. 901 M 901 ML Pulse Oximetry System Technical Information and Service Manual CONTENTS 1 PRELIMINARY REMARK lt lt lt pe ea e eet EE ee RUE 4 2 FUNCTION DESCRIPTION pct P NN UR a 5 21 INTENDED US E ne D RUNE 5 22 GONTRAINDIGATION aorta cena ein ene ee 5 2 3 PRODUCT DESORIPTJION redet edu 5 2 4 THEORY OF OPERATION gia eaters de tee ee e De ats 6 3 TECHNICAL DESCRIPTION OF THE 9 1 901 7 3 1 DISPLAYS AND CONTROLS Us teet tui Pug 7 3 1 1 csv mes cts dim ep e e urea ins coy cdita e tuta AEAEE a E arcad 7 3 1 2 EETA GOVE CES 7 3 1 3 Back M E doccia tta E N 8 3 2 CONNECTIONS ON THE eta Vetro 8 S02 BEOCIDIAGBANIG b s tus nette optas is 8 34 POWER SUPPLY pado ee pov viaa e ese 9 S02 ONOFR BUTTON s 3 6 MASIMOBORBRDS d eto ee eben e ies 10 3 7 MICROPROCESSOR AND PERIPHERALS 10 3 8 SELF DIAGNOSTIC CAPABILITY OF THE 901 901 11 3 8 1 Watchdog and undervoltage reset eese 11 3 8 2 ROM check
7. Loudspeaker check The loudspeaker is checked once after program start and then each 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 3 8 8 Stack monitoring The stack is continually monitored for overflow status If the stack pointer exceeds a pre defined limit a system alarm is generated 3 8 9 Detection of an 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 12 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 13 4 MAINTENANCE PROCEDURES This chapter covers the following items Regular maintenance procedures to be carried out on the 901 M 901 ML 4 1 Preliminary remark The following 901 M 901 ML components are subject to wear e Li battery 901 M 901 ML Lilon battery 901 ML only All other components are not subject to ageing 4 2 Li battery replacement The manufacturer recommends replacing the Li bat
8. M 901 ML 7 The 901 M 901 ML automatically switches off 23 8 DATA DOWNLOAD PROGRAM DOWNLOAD901 This chapter covers the following items e Using the Download901 program e Performing data download 8 1 Preliminary remark The Download901 program allows you to transmit stored monitoring data from the sat801 to a PC This data can be further analyzed by an oximetry program such as TrendLibrary 8 2 General information about Download901 With Download901 you are able to e set and synchronize the system time of the 901 M 901 ML perform a data download procedure 8 3 Downloading data 1 Setup the connection between the PC and the 901 M 901 ML 2 Start Download801 3 Turn on the 901 M 901 ML 4 Automatically the current 901 M 901 ML time setting S N and software version are transmitted to the PC and displayed 2 901 Communication PC ime 16 06 2008 18 10 41 901 S N 03000000 901 time 1 06 2008 18 10 33 iat Venti 42000 Transfer PC time Download data 5 Click on Transmit to allow for the data download The data download starts 24 2 901 Communication 901 time 5 06 2008 18 11 15 SW Version 4 02 TransferPCtme Download data PENATAN 6 You will then be prompted for the target file Speichern unter Speichern in 901 ek E3 9 Zuletzt verwendete D Desktop ns Eigene Dateien Arbeitspla
9. intervals If this voltage is below the specified threshold the device switches to battery mode 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 3 5 button When the ON OFF button is pressed the 901 M 901 ML is waked from the sleep mode 3 6 Masimo board The Masimo OEM board and the CPU communicate via a 9600 baud serial interface 3 7 Microprocessor and peripherals A microcontroller type ATMEL Atmega 329V controls the task sequence of the 901 M 901 ML 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 a timer output pitch signal and a pulse width output volume signal This solution relieves the mic
10. items e Using the service program e Performing software updates 7 1 Preliminary remarks The service program allows you to read out modify and save again device constants parameters and settings stored in the 901 M 901 ML In addition it can be used to update the 901 M 901 ML 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 7 2 General information about the Service901 The welcome screen appears after starting the 901 M 901 ML service program Alarm limits Acoustics Mode sat901 Parameters 5 02 high Pulse tone Access code clinic 301 S N 5 02 low Alarm tone code home Mainboard S N E Home Clini Pulse high Al suppr time Masimo Board S N C HomeCare Mode Pulse low Clinic Mode Masimo Data mode Averaging time werwrite SW Version C Freeze Sensitivity m turn on the 901 In the left area you are able to display and modify alarm limits for SpO2 and Pulse Rate display and modify the SpO2 signal processing algorithm parameters such as averaging time and sensitivity display and modify the acoustical settings display and modify the access codes for clinical and home care mode 21 In the right area you are able to e identify the serial numbers for the internal PCBs e identify the firmware version perform a firmware upd
11. Y LOUDSPEAKER uicti trm e ih 17 5 7 ERROR DISPLAY VALUES NOT PLAUSIBLE AND OR FAULTY 17 6 901 M 901 ML CHECK ROUTINE eee eie vence eo cede es Ned ie dus 18 6 1 PRELIMINARY WEES da pate 18 6 25 POWER SUPPLY CHECK p ie 18 DEVICE SELF TEST AND BRIEF 18 ALARM LIMITS CHEQGNK ertet retener rettet epit e oett ieu 19 SENSOR ALARMS CHECK orte ttr epe opti ee Pra rotuli 19 ACOUSTIC SIGNALS OhEQGN e dee doe 20 DEVICE VALIDATION La Race th ire Deseos 20 PC fu 20 SERVICE PROGRAM SERVICEQ01 eene enne nnne nennen neni 21 PRELIMINARY REMARKS a tei Eno te tac eeu 21 GENERAL INFORMATION ABOUT THE SERVICE901 21 PERFORMING A PARAMETER UPDATE seen 22 PERFORMING A SOFTWARE UPDATE ritiro nete tite tete 23 DATA DOWNLOAD PROGRAM DOWNLOAD9O1 24 PRELIMINARY REMARK uino doter NIST D c emen 24 GENERAL INFORMATION ABOUT DOWNLOAD901 24 DOWNLOADING DER itii eaae t hoa rtis ete io ste 24 SETTING TIME JAND BATE cierre Se edet 26 1 PRELIMINARY REMARK This technical information requires the knowledge of the 901 M 901 ML Instructions for Use manual It is assumed tha
12. ard are constantly checked for start and stop bytes as well as for checksum If no new data package 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 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 3 8 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 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 3 8 7
13. ate 7 3 Performing a parameter update 1 Setup the connection between the PC and the 901 M 901 ML 2 Start Service901 The welcome screen is displayed 3 Turn on the 901 M 901 ML 4 All stored parameters are displayed amp 901 Communication Alarm limits Acoustics Mode sat901 Parameters 5 02 high 100 Pulse tone 5 Access code clinic 1968 901 S N 03000000 5 02 low 88 Alarm tone 5 Access code home 2606 Mainboard S N 071011160242 Pulse high 160 Al suppr time 505 Home Lini Masimo Board S N 45065443 HomeCare Mode SW Version 4 02 Pulse low 40 Clinic Mode ded Data mode Averaging time werwrite C Freeze Sensitivity Transmit Update 5 Perform the necessary modifications in the masks 6 Click on the Transmit button to allow for parameter update of the sat801 5 901 Communication Alarm limits Acoustics Mode sat801 Parameters 5 02 high 100 Pulse tone 1 Access code clinic 1968 901 S N 03000000 5 02 low 88 Alarm tone 1 Access code home 2606 Mainboard S N 071011160242 Pulse high 160 Al suppr time 505 Hone Cini Masimo Board 5 N 45065443 C HomeCare Mode SW Version 4 02 Pulse low 40 Clinic Mode Masimo Data mode Averaging time werwrite T Sensitivity Freeze 7 Remove the USB cable from the 901 M 901 ML 8 The 901 M 901 ML automatically switches off 22 a Performing a software update Turn on the 901 M 901 ML
14. 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 901 M 901 ML 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 901 M 901 ML 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 901 M 901 ML 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 901 M is internally powered by 2 AA batteries whereas the 901 ML has a built in Lilon rechargeable battery Both models can also run with an external DC power supply 24 Theory of operation The function principle of the 901 M 901 ML 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 li
15. ght absorption by the blood and the arteriovenous 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 of the 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 901 M 901 ML 3 1 Displays and controls 3 1 1 Front LCD Display Green Power LED Yellow Alarm LED Red Alarm LED Backlight button Eg and Down arrow navigational button Menu button 7 On Off button X 8 Alarm mute button e and A OO N Up arrow navigational button B Fig 1 Front 3 1 2 Back 901 M 1 Loud speaker 2 Battery compartment 3 Battery compartment lock Fig 2 Back 3 1 3 Back 901 ML 1 Loud speaker and type plate 3 2 Connections on the unit Connections on the upper panel of the unit
16. 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 16 5 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 5 7 Error Display values not plausible and or faulty Error situation The displayed 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 17 6 901 M 901 ML CHECK ROUTINE This chapter covers the following items e Complete check routine for testing the 901 M 901 ML function 6 1 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 62 Power supply check Action Result e Connection of plug in power pack to public power supply e Green LED on plug in power pack comes on Connection of plug in power pack to the 901 M 901 ML e Green LED comes 6 3 Device self test and brief check Action Result Switching the device on using the ON OFF button 901 M 901 ML performs several self tests in short succession e Watchdog test internal
17. rocontroller from the task of direct waveform generation and ensures a good tone quality The loudspeaker can be tested for short circuit and no contact error conditions If such a system occurs an additional buzzer will be activated 3 8 Self diagnostic capability of the 901 M 901 ML 3 8 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 3 8 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 If the ROM check is not passed a system alarm is generated 3 8 3 RAM check The whole internal RAM area is checked once before the major loop is started If the RAM check is not passed the 901 M 901 ML is rebooted 3 8 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 3 8 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 bo
18. rom 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 6 6 Acoustic signals check Action Result Selection of alarm tone volume from 1 to 10 Alarm tone volume varies from very low to very loud Selection of alarm tone OFF Alarm tone is switched off At the same time the symbol appears on the LC display Selection of pulse tone volume from 1 to 10 Pulse tone volume varies from very low to very loud Selection of pulse tone OFF Pulse tone is switched off 6 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 6 8 Brief check A brief check is carried out by allowing the device to complete its self test 1 Connect the 901 M 901 ML to the public power supply via the plug in power pack 2 Switch the 901 M 901 ML 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 901 M 901 ML off 20 7 SERVICE PROGRAM SERVICE901 This chapter covers the following
19. t the operation and menu structure of the 901 M are known In individual cases it is necessary to use the Instructions for Use manual together with this technical information 2 FUNCTION DESCRIPTION 2 1 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 LNCS 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 LNCS 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 901 M 901 ML pulse oximetry system comprises the 901 M 901 ML pulse oximeter based on the Masimo SET technology a plug in power pack a patient cable and different disposable or reusable SpO2 sensors The 901 M 901 ML pulse oximeter consists of a housing that is suitable for stationary
20. tery at 10 year intervals Note Since the service philosophy is a complete replacement strategy the Lithium battery may only be changed in the manufacturer s service department 4 3 Lilon battery replacement The manufacturer recommends replacing the Lilon battery at 3 year intervals Note Since the service philosophy is a complete replacement strategy the Lilon battery may only be changed in the manufacturer s service department 14 5 POSSIBLE ERRORS AND THEIR CORRECTION This chapter covers the following items e Description of possible errors e Information about their causes and correction 5 1 Error System alarms 5 1 1 Hardware related system alarms All hardware related system alarms need to be serviced at the manufacturer 5 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 5 3 Error 901 M 901 ML cannot be switched on in battery mode Error situation 901 M 901 ML cannot be switched on in battery mode Error correction 1 Replacement of the batteries 2 Hardware failure send unit in 5 4 Error 901 M 901 ML will not switch on in mains mode Error situation 901 M 901 ML will not switch on in mains mode Error correction 1 Check function of plug in power supply 2 Hardware failure send unit in 5 5 Error Yellow and or red alarm LEDs do
21. tz Netzwerkumgeb Dateiname 030000000009 bal ung Dateityp TrendLibrary files sat Abbrechen 7 7 After successful storage of the file remove the USB cable from the 901 M 901 ML 8 The 901 M 901 ML automatically switches off 25 8 4 Setting time and date using Download901 Setup the connection between the PC and the 901 M 901 ML Start Download801 Turn on the 901 M 901 ML Automatically the current 901 M 901 ML time S N and software version is transmitted to the PC and displayed 3 901 Communication 901 time 16 05 2008 18 14 39 SW Version 402 Transfer PC time Download data 5 Synchronize the PC time with the 901 M 901 ML time by clicking Transfer 6 7 time 2 901 Communication 901 time E 5 06 2008 16 15 01 SW Version 4 02 Download data Remove the USB cable from the 901 M 901 ML The 901 M 901 ML automatically switches off 8 5 Setting time and date on the unit 1 Press and hold the menu button 2 Switch the unit on 3 4 5 The unit displays d1 year Set the correct year using the up B and down c buttons Press the menu button e 26 The unit displays d2 month Set the correct month using the up down buttons 6 7 8 Press the menu button B 9 The unit displays d3 day 10 Set the correct day using the up and down buttons 11 Press the menu button
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