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Bitmos sat 801+ Manual Download Page 13

 Pulse Oximeter 

 

Technical data 

 

 

 

13 

 

NOTICE! 

A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a 
pulse oximeter

.

 

NOTICE! 

If there is independent demonstration that a particular calibration curve is accurate for the 
combination of a pulse oximeter and a pulse oximeter probe, then a functional tester can 
measure the contribution of a monitor to the total error of a monitor/probe system. The 
functional tester can then measure how accurately a particular pulse oximeter is 
reproducing that calibration curve

. 

 

Perfusion 

Display range 

0.02-20.0 % 

 

Setting range of the alarm limits  

Upper Limit oxygen saturation 

42-100 % 

Lower Limit oxygen saturation  

40-98 % 

Upper Limit pulse frequency 

27-240 1/min 

Lower Limit pulse frequency 

25-238 1/min 

Alarm tone loudness 

75 dbA 

 

Sensor 

Wavelengths 

660 nm (red), 905 nm (infrared) 

max. light intensity 

0.79 mW 

 

Notice! 

Information about wavelength range can be especially useful to clinicians. 

 

Summary of Contents for sat 801+

Page 1: ... Bitmos GmbH Himmelgeister Straße 37 D 40225 Düsseldorf Germany Tel 49 0 211 60 10 10 30 Fax 49 0 211 60 10 10 50 E Mail info bitmos de Internet www bitmos de 36 8101 EN TD075215 09 12 2013 ...

Page 2: ...it 18 4 5 USB Interface 18 5 Shipping Packaging and Storage 20 5 1 Shipping inspection 20 5 2 Packaging 20 5 3 Storage 20 6 Use 21 6 1 Environmental Conditions 21 6 2 Prior to initial use 21 6 3 Energy supply 21 6 3 1 Mains connection 21 6 3 2 Battery operation 22 6 3 3 Changing the energy supply 24 6 3 3 1 Changing from mains to battery supply 24 6 3 3 2 Changing from battery to mains supply 25 6...

Page 3: ...raging time 47 7 6 3 2 Perfusion Sensitivity Algorithm mode 48 7 6 3 3 SmartTone SmartTone 49 7 6 3 4 Artifact filter Artifact filter 50 7 6 4 System time Clock 51 7 6 5 Device information Product Info 51 8 Alarms 52 8 1 In General 52 8 2 Alarm filter 52 8 3 Alarm categories 53 8 3 1 High Priority Alarms 54 8 3 1 1 SpO2 alarm 54 8 3 1 2 Pulse rate alarm 54 8 3 1 3 Sensor alarms 54 8 3 1 4 System A...

Page 4: ...ing of the Masimo Sensors 67 11 1 3 Cleaning of Patient Cables 68 11 2 Maintenance 68 11 2 1 Yearly Maintenance 68 11 2 2 User Check of Alarm Function 68 12 Accessories and replacement parts 70 12 1 Accessories 70 13 Advanced information 71 13 1 Averaging time 71 13 2 Alarm signal generation delay 72 14 Index 73 ...

Page 5: ... in these operating instructions are designated by symbols These specified notices on industrial safety must be strictly complied with and adhered to Behave cautiously in these cases especially in order to avoid accidents damages to unit and people CAUTION Injury or Mortal Danger This symbol marks notices that if not observed can lead to health impairments injuries lasting bodily injury or to deat...

Page 6: ...plicable Translations of the operating instructions also have been provided to the best of our knowledge However we cannot accept liability for translation errors The text and graphic representations do not correspond necessarily to the supply scope The designs and diagrams do not correspond to the scale 1 1 The current supply scope can vary from the presently described data and notices as well as...

Page 7: ...02 952 5 919 134 5 769 785 5 758 644 5 685 299 5 632 272 5 490 505 5 482 036 and their international equivalent patents Other US and international patents are pending Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would alone or in combination with this device fall into the scope of one or more of the...

Page 8: ...ted a more exact investigation is immediately necessary ATTENTION Each use of the unit beyond that recommended by law and or misuse is forbidden and is considered to be in violation of the law Claims of any kind against the manufacturer and or its authorized personnel on account of damage from improper use of the unit are forbidden The user of the unit is solely responsible for all damages resulti...

Page 9: ...Hb will affect the accuracy of the SpO2 measurement For increased COHb COHb levels above normal tend to increase the level of SpO2 The level of increase is approximately equal to the amount of COHb that is present NOTE High levels of COHb may occur with a seemingly normal SpO2 When elevated levels of COHb are suspected laboratory analysis co oximetry of a blood sample should be performed Elevated ...

Page 10: ...logy And yet risks remain WARNING Health Risk Particular supervision is necessary if the unit is used near children or bedridden individuals Use with small children may never occur without additional monitoring WARNING Danger from Electrical Current Electrical power can cause severe injuries Damaging the insulation or individual parts is life threatening Therefore Work on the unit may only take pl...

Page 11: ...at least 30 The unit may not be exposed to strong magnetic fields during operation Magnetic fields in the network frequency must correspond to typical values found in business or hospital environments 2 4 Users The unit may only be used by trained specialists and instructed users The configuration of the unit e g the alarm limits in particular has to take place with corresponding medical expertise...

Page 12: ...th LNOP Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory cooximeter and ECG monitor This variation equals plus or minus one standard deviation which encompasses 68 of the population The Masimo SET Technology with LNOP Adt sensors has been validated for motion accuracy...

Page 13: ...itor to the total error of a monitor probe system The functional tester can then measure how accurately a particular pulse oximeter is reproducing that calibration curve Perfusion Display range 0 02 20 0 Setting range of the alarm limits Upper Limit oxygen saturation 42 100 Lower Limit oxygen saturation 40 98 Upper Limit pulse frequency 27 240 1 min Lower Limit pulse frequency 25 238 1 min Alarm t...

Page 14: ...rm limit Pulse high 160 1 min Alarm limit Pulse low 40 1 min Alarm filter SpO2 low Off Alarm filter Pulse high Off Memory configuration Permanent overwrite SmartTone On Alarm tone volume 5 Pulse tone volume 5 Alarm tone mute time 60 sec Averaging Time 8 sec Perfusion sensitivity normal Artifact filter Off Mode access permissions Clinic ...

Page 15: ...vigation button right up 6 On Off button 7 Loud speaker 8 Alarm mute button 9 Menu OK button 10 Navigation button left down 11 yellow alarm LED Fig 1 Front 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 2 Upper panel of unit 1 2 11 3 10 6 7 8 9 4 5 ...

Page 16: ...capacity in 6 lower and upper oxygen saturation alarm limit 7 Alarm tone mute symbol if the audio alerts are temporarily suppressed Alarm paused if the audio alerts are switched off Alarm off 8 Status line Alarm messages clock and other information parameters are displayed dependent on the menu selection 9 lower and upper pulse rate alarm limit 10 AL symbol displayed with activated ALarm filter an...

Page 17: ...t an arterial pulse signal the lower the presented IQ bar The Signal IQ figure is particularly valuable with movement weak circulation or environmental influences What is the Perfusion Index The Perfusion Index is a measurement for pulse strength at the point of sensor measurement The Perfusion Index varies from 0 02 very weak pulse strength to 20 very strong pulse signal The Perfusion Index is ca...

Page 18: ...button left down Alarm tone mute IP 22 Ingress Protection Rating Manufacturer Ambient pressure range storage condition Humidity storage range condition Temperature range storage condition Model number Serial number Defi proof applied part type BF 4 5 USB Interface ATTENTION To connect to the interface use only original manufactured parts Otherwise the unit could be damaged ...

Page 19: ... has a built in mini USB Interface 1 NOTICE It is not possible to connect the patient connector and the USB cable at the same time NOTICE The necessary Interface software is available from the medical devise supplier or directly from Bitmos GmbH 1 Fig 3 USB Interface ...

Page 20: ...you save the packaging WARNING Risk of Suffocation Packaging materials are not intended for children The danger of suffocation exists ATTENTION Always dispose of packaging materials in environmentally correct manner and according to local disposal regulations If need be call the recycling company 5 3 Storage Only store the unit under the following conditions For longer periods of storage charge th...

Page 21: ... first time familiarize yourself with it and its accessories This absolutely includes reading the user manual WARNING Danger to the Patient The unit is used to monitor patients That is why it should only be used and configured by trained and instructed users Before using the unit on a patient for the first time it must be turned on and tested 6 3 Energy supply 6 3 1 Mains connection Electricity fo...

Page 22: ...ternal power supply unit it can also be provided by the built in battery With a fully charged battery the power supply is guaranteed for at least 22 hours of monitoring When the device is switched on the current battery capacity is permanently displayed to the user as an icon on the LCD display If the battery capacity is no longer sufficient in other words monitoring is guaranteed for less than 1 ...

Page 23: ...The green power LED 1 displays NOTICE The green power LED only signals that the unit is supplied with electricity The LED does not show the unit s operating condition ON OFF 4 For charging the unit remain the unit plugged in for 8 hours with the unit switched off and for 9 hours when switched on Fig 7 Power LED NOTICE When switched on the battery capacity is displayed in the display ...

Page 24: ...ng from mains to battery supply 1 Unplug the power supply from the mains network 2 Unplug the power connector 1 from the unit 2 2 1 Fig 8 DC power plug 3 The power LED 1 goes dark Fig 9 Power LED 4 In case the device is switched on for 30 seconds a mains failure alarm is triggered The yellow alarm LED is triggered and the status line shows the message Mains power failure Fig 10 Mains power failure...

Page 25: ...The device is in battery operation 1 Connect the DC power plug to the unit connector 2 Plug the other end of the cable into a mains electric outlet 2 1 Fig 12 DC power plug 3 The power LED 1 goes on 4 The unit is now supplied by mains NOTICE The green power LED only signals that the unit is supplied with electricity The LED does not show the unit s operating condition ON OFF Fig 13 Mains power LED...

Page 26: ...Sensor 1 2 Fig 14 Connect patient cable 3 Insert the sensor connector into the patient cable connector The plug only fits in one direction and can be felt snapping in NOTICE Some Masimo sensors e g type LNOP DCSC come with an integrated patient cable In this case connection to a separate patient cable is not necessary Fig 15 LNOP sensor connection Fig 16 LNCS sensor connection ...

Page 27: ...ling LNCS sensors 1 Lift the protective cover 1 2 Pull firmly in the sensor connector to remove from the patient cable 2 Fig 18 LNCS sensor coupling 6 4 3 Disconnecting the patient cable from the unit 1 Press the two disconnect buttons 1 at the patient cable socket together The locking mechanism unlocks the patient cable 2 Remove the connector ATTENTION Do not apply pressure when removing the plug...

Page 28: ...ING Danger from equalizing current Never touch the patient and the external connections of the unit at the same time The health of the patient can be influenced from possible equalizing current occurrence ATTENTION Unit can fall Secure the unit s location It can be damaged when falling or even injure the patient Never lift the unit by one of its connectors They could be damaged Battery operation m...

Page 29: ...or too tightly Inspect the sensor site as directed in the Instructions for Use to ensure skin integrity and correct positioning and adhesion of the sensor Do not use damaged sensors or cables Do not use a sensor with exposed optical components The sensors as well as the patient cable connectors are not waterproof Never immerse the sensors or connecting elements in liquid or hold under running wate...

Page 30: ...sitive skin 16 1798 LNOP Neo L Newborns 10 kg 16 1800 LNOP Inf L Small Children 3 kg 10 kg 16 1651 LNOP NeoPt L Newborns 1 kg sensitive skin 16 1611 LNOP Neo Bridge Newborns 10 kg 16 1859 LNCS Adtx Adults 30 kg 16 1860 LNCS Pdtx Children and Adults 10 kg and 50 kg 16 2328 LNCS Inf L Small Children 3 kg 20 kg 16 2329 LNCS Neo Newborn children adults 3 kg or 40 kg 16 2330 LNCS NeoPt Neonatal Preterm...

Page 31: ...tive 16 1863 LNCS DCI Adults 30 kg 16 1864 LNCS DCIP Children 10 kg and 50 kg 16 2258 LNCS YI Children and Adults multisite 1 kg 16 1895 LNCS TC I Adults and Children 30 kg ear sensor 16 1896 LNCS TF I Forehead sensor transflective adults 30 kg WARNING Danger with long term application The use of reusable Masimo LNOP and LNCS sensors is contraindicated with long term application These sensors are ...

Page 32: ... display are highlighted to assist in understanding In addition the following writing format is used Display text 7 2 Menu operation 7 2 1 Using the menu buttons In the menu down or left or decrease settings In the menu up or right or increase settings Confirm actions or selections Fig 20 Operation Notice If you do not confirm or accept a menu setting within 60 seconds the standard screen is autom...

Page 33: ...Total alarm list Alarm lists Trend On screen data display Memory config Data Erase Memory Memory configuration Acoust Alarms Volume pulse Volume alarm Mute duration Configuration of the acoustical alarms Signal process Algorithm mode Averaging time Smart Tone Artifact filter Setting of pulse oximetry parameters Screen Backlight Mode Language Adjustment of the screen options and Access permissions ...

Page 34: ...rm tone volume setting is 5 or less a warning message is displayed during the power up cycle The operator has to acknowledge this setting with OK Otherwise the device will not enter the standard mode Fig 23 Too silent alarms warning ATTENTION No alarms in SLEEP LAB MODE With activated SLEEP LAB MODE there are no acoustical alarms on the unit If activated the operator has to confirm this setting wi...

Page 35: ...ot be used on the patient Fig 26 Defective loud speaker 3 After this the Normal Display appears With an applied sensor now the signal search for the pulse occurs message Pulse search in the status line With a successful pulse search the measured values for oxygen saturation and pulse frequency are displayed on the screen Fig 27 Normal display 4 The unit is now operational 7 4 Turning the unit off ...

Page 36: ...ress the On Off button for approx 2 seconds 2 The display shows the turn off confirmation message 3 Press the On Off button again NOTICE Should the On Off process be interrupted the last readings before the On Off process appear for approx 5 seconds The monitoring remains intact for the entire time 4 The unit is now being turned off Fig 28 Power down screen ...

Page 37: ...ication procedure is interrupted or cancelled this value persists If implausible alarm limits are set e g the lower limit value is greater than the higher value the device responds with the error message Alarm limits are not correct to the Accept request In this case the alarm limits selected are not accepted as new values NOTICE The difference between the upper and lower alarm limit values must t...

Page 38: ...for setting the upper pulse rate alarm limit or select PR lo for setting the lower pulse rate alarm limit 3 Select the alarm limits to be changed Fig 31 Modifying the alarm limits 4 Set the new value Fig 32 Confirming the alarm limits 5 Confirm the new value 6 Confirm the new setting by confirming the safety question Accept Y N Fig 33 Confirming the alarm limits ...

Page 39: ...larm condition for oxygen saturation and or pulse rate will NOT lead to an acoustical nor optical alarm After the above mentioned alarm filter time period the alarm will be generated If in the meantime the source of the alarm condition will vanish there will be no alarm at all The alarm filters can be configured individually for SpO2 low and also for pulse rate high This feature will increase user...

Page 40: ...lue and confirm it Fig 35 Modifying the alarm filter 5 Set other values if needed 6 Leave the menu with Return 7 Confirm all new values by confirming the safety question Accept Y N 9 If the alarm filter is activated this will be displayed by the symbol AF in the lower right area of the display Fig 36 Confirming the settings ...

Page 41: ...This function activates the LCD backlight settings are ON and AUTO The ON setting switches the background lighting permanently to maximum brightness The AUTO setting dims the background lighting to a default minimum value When high priority alarms are triggered the background lighting is automatically switched to automatic When the alarm condition goes off the background lighting is similarly auto...

Page 42: ...nguage Language This function sets the menu language 1 Starting from the main menu call Configuration Screen Language 2 Select the desired language NOTICE The changes made will be effective with immediate effect 3 Confirm the selection Fig 40 Language 7 6 1 3 Access permissions Mode Starting from the main menu call Configuration Mode Following access permissions may be either set Home Care Mode Ho...

Page 43: ...ese parameters are invisible The Clinic mode access allows users to set all the configuration parameters The Sleep Lab mode will turn off all alarms during monitoring This is useful for overnight sleep studies CAUTION Alarms cannot be detected If in Sleep lab mode an alarm condition occurs the operator will not be alerted by acoustical means ...

Page 44: ...Backlight Language Access permission Date and time Product info not allowed allowed Setting the access permission 1 Starting from the main menu call Configuration Screen Mode 2 Select Home Clinic or Sleep lab and confirm 3 Enter the four digit pin code for the respective access permission NOTICE The pin code is located in a separate document Call the manufacturer 4 Select the first digit 5 Set the...

Page 45: ...time Silence Time Fig 44 Acoustical alarm 7 6 2 1 Pulse tone volume Volume Pulse When the pulse signal tone is activated then in monitoring mode a tone signal will be played for every detected pulse The pitch of the tone identifies the current oxygen saturation In other words the higher the pitch of the tone the greater the measured oxygen saturation and vice versa 1 Starting from the main menu ca...

Page 46: ...ay shows the permanent alarm silence symbol NOTICE If you select a setting of less than 5 a warning message is displayed during the next power on cycle reminding the operator at a possibly too silent setting NOTICE In home care mode audio mute setting OFF is not possible Fig 46 Alarm tone volume 7 6 2 3 Alarm mute time Silence Time The alarm signal mute time displays the duration of the mute signa...

Page 47: ...ion 7 6 3 Masimo Signal Processing Signalprocessing Starting from the main menu call Configuration Signalprocessing Following actual signal processing parameters can be set Averaging time Averaging time Sensitivity Algorithm mode Smart Tone on off Artifact filter on off Fig 48 Masimo signal processing 7 6 3 1 Averaging time Averaging time The averaging time indicates the duration with which from s...

Page 48: ...al Norm perfus High low perfus and APOD APOD The normal Perfusion Sensitivity has been optimized for continuous long term monitoring Depending on signal quality the lower signal strength value lies between 0 5 and 0 02 The higher Perfusion Sensitivity lower perfusion may only be used for supervised clinical situations This setting is dependent on the sensor alarms since it is only activated for si...

Page 49: ...t and display data for even the weakest of signals and is recommended during procedures and when clinician and patient contact is continuous If low perfusion combined with movement inhibits the Masimo SET monitor from reading switch from APOD to Normal or Max sensitivity Three sensitivity levels enable the clinician to tailor the response of the sat801 to the needs of the particular patient situat...

Page 50: ...martTone 7 6 3 4 Artifact filter Artifact filter The Artifact filter rejects sensor related alarm messages that are shorter than 5 seconds A sensor alarm must be at least for 5 seconds of the same type to be processed 1 Starting from the main menu call Configuration Signal process Artifact filter 2 Select the setting on off 3 Confirm this setting with RETURN Fig 52 Artifact filter ...

Page 51: ... run while setting it For that reason it makes sense to set the clock time to a later point in time and then at precisely that point in time accept the time and date Fig 53 Setting the system time If you try to accept an invalid date e g 30 02 13 the device responds with the following message Date is not correct In that case no new date or time is set 7 6 5 Device information Product Info By selec...

Page 52: ...eam Excessive light intrusion such as operating lamps especially xenon light sources bilirubin lamps fluorescent lights infrared heat sources or direct sun light excessive light intrusion can be avoided with a dark or transparent sensor shade Excessive movement of the patient Venous blood pulse Connection of the sensors is to a body part already connected to a blood pressure cup an arterial cathet...

Page 53: ...erated If in the meantime the source of the alarm condition will vanish there will be no alarm at all The alarm filters can be configured individually for SpO2 low and also for pulse rate high This feature will increase user compliance by suppressing short alarm periods The alarm filters are deactivated when shipped from the factory 0 OFF 8 3 Alarm categories There are four alarm categories High p...

Page 54: ...und Alarm OFF has been selected no alarm is heard The alarm condition is then only displayed as an optical signal Fig 54 High Priority Alarm Indicator 8 3 1 1 SpO2 alarm Status line message Message in the LC display Cause SpO2 flashing SpO2 value oxygen saturation exceeds the set alarm limit SpO2 flashing SpO2 value oxygen saturation falls below the set alarm limit The elapsed duration of the curr...

Page 55: ...orrectly monitored The patient s condition must be assessed by other means A system alarm indicates that reliable monitoring is no longer being performed due to a technical error The unit can and may no longer be used when this alarm occurs For System Alarm the high level alarm sound is heard the red alarm indicator blinks 1 and system alarm message in the status line Fig 55 System Alarm Indicator...

Page 56: ...ansfer has a permanent defect SYST ALARM MS error The Masimo circuit board has reported an irreparable defect SYST ALARM Unexp reset An unexpected device restart has occurred SYST ALARM NVRAM error The internal non volatile memory has reported an error SYST ALARM WDT error The integrated circuit that monitors the sat801 has reported an error SYST ALARM Stack overfl An error has occurred in the sof...

Page 57: ...l Priority Alarm Indicator Mid level Priority Sensor Alarms Possible Cause Description Solution Sensor defect The unit has determined the sensor does not work or only with limited capacity Exchange the sensor with a new Masimo Sensor Interference The unit has determined influence from a second light source or a second sensor Remove the interfering source Only use a new Masimo sensor Ambient Light ...

Page 58: ...8 Possible Cause Description Solution Unknown Sensor The unit has discovered a sensor not approved for this system Only connect approved Masimo sensors Battery depleted Remaining operation time of 15 minutes or less Recharge battery ...

Page 59: ...rity is activated With concurrently occurring alarms the highest ranking is activated If these alarm conditions are removed the next lower waiting alarm is immediately displayed A new alarm condition of higher priority immediately supersedes any lower ranking alarm 8 5 Status message The following status messages provide information about the actual monitoring situation Possible Cause Description ...

Page 60: ...a list of all alarm events the vital alarm list trend displays The stored data can be exported via various interfaces for more detailed evaluation 9 1 1 Vital alarm list Vital alarm list 1 Starting from the main menu call Data Vital alarm list The list of vital alarms is displayed From left to right this shows the serial alarm ID e g no 89 date and time when the alarm occurred e g 16 08 12 11 59 h...

Page 61: ...and to show an older alarm i e lower alarm numbers 3 Leave the list by confirming Return Fig 58 Total alarm list 9 1 3 Alarm details 1 Call the alarm list 2 Mark an alarm entry and select it In the window following information is displayed start date start time alarm duration type of alarm here PR hi alarm limits extreme value or type of alarm 3 Leave the window by confirming Return Fig 59 Alarm d...

Page 62: ...ayed in the required format 4 Press to move the pointer to later times and to move to earlier times Fig 60 Trend display At the current position the position of the screen marker are displayed Left minimum lower value and maximum upper value at that point in time is displayed if there are no values available Lower Line selected display mode time scale 4 minutes till 24 hours Date here 16 08 12 and...

Page 63: ...ccepts empty erased micro SD cards All other cards will be refused with an error message Fig 61 Card not erased 1 Switch off the device 2 With the angled edge to the front and the exposed contacts facing downwards introduce the empty SD card into the slot until it is firmly in place Fig 62 Inserting SD card 3 Switch on the device It automatically detects the SD card and goes into data transmission...

Page 64: ...e SD card in this event 4 Pull the SD card out The data on the SD card can then be processed with a graphics and analysis program e g Bitmos satview Fig 64 Removing the SD card 9 3 2 USB connection Data can also be transferred by USB 1 Switch off the device 2 Connect the computer to the sat801 via a mini USB cable 3 Switch on the device The USB connection is automatically detected and displayed on...

Page 65: ...east Should function not occur even with a networked connection inform medical device supplier When in use buttons do not work Internal failure Inform medical device supplier Error message after self test run and after unit is turned on Internal failure Turn the unit ON and OFF Inform medical device supplier Defective loud speaker Defective alarm loudspeaker Inform medical device supplier Sensor n...

Page 66: ...n Patient The sensor is connected to the unit the unit is on but no patient can be recognized Position the sensor correctly Ambient Light The unit has determined a scattered or foreign light source This can occur with particularly strong lighting from the outside especially from xenon or similar lamps Do not expose the sensor to a direct light source or shade from the outside Unknown Sensor The un...

Page 67: ... gas sterilization 1 Before cleaning turn the unit OFF and disconnect from the network and the patient 2 Only clean the unit with a dry or slightly moist cloth For more severe soiling use a moist cloth and all purpose cleaner 3 Let the unit dry completely before re use 11 1 2 Cleaning of the Masimo Sensors The re usable Masimo sensors are to be cleaned as follows 1 Disconnect from the patient cabl...

Page 68: ...l tester can measure the contribution of a monitor to the total error of a monitor probe system The functional tester can then measure how accurately a particular pulse oximeter is reproducing that calibration curve 11 2 1 Yearly Maintenance The unit should be checked by the manufacturer or an authorized dealer once a year Contact the medical device supplier for the correct information 11 2 2 User...

Page 69: ...y will be accepted The alarm will activate The red LED blinks and the alarm will sound 7 Reset the upper alarm limit to a value of 10 1 min above the indicated pulse frequency value The new alarm value will be accepted The alarm goes silent 8 Set the lower alarm limit to a value of 10 1 min above the indicated pulse frequency value The new alarm value for the lower pulse frequency will be accepted...

Page 70: ...reements are void without prior notice by the use of unapproved accessories or replacement parts 12 1 Accessories Only use original supply parts from the manufacturer Order No Item 36 5005 XY Plug in power supply XY EU Europe XY UK Great Britain XY US USA XY SAA Australia 36 1103 Universal mounting bracket Plexi glass 36 2302 Carrying case 36 9008 Software satView 36 9002 USB cable 36 9010 Softwar...

Page 71: ...rve 1 Curves 3 and 4 underestimate the depth of the fall in saturation Curve 2 faster averaging can cross a low saturation alarm limit sooner than curve 3 normal averaging or curve 4 slower averaging which might not cause an alarm condition at all The benefit of normal and slower averaging is to smooth out the otherwise noisy signal and reduce the number of false positive alarm conditions ...

Page 72: ...he pulse oximeter equipment processing and averaging is t2 t1 the alarm condition delay The interval t3 t2 the alarm signal generation delay is attributed to the alarm system strategy and the communication time to the alarm signal generation device or distributed alarm system e g patient monitor or central station Thus the overall alarm system delay time is t3 t1 ...

Page 73: ... Averaging time 71 Averaging time 47 B Backlight 41 Batteries 10 Battery Alarm 59 Battery operation 22 C Changing the energy supply 24 Cleaning 67 Clinic 42 Clock 51 Combination of Alarms of different Priorities 59 Configuration 41 Connections 15 25 Controls 15 Copyright protection 7 Customer Service 11 D Dangers 10 Data export 63 Default settings 14 Device information 51 Display 15 Disposal 20 Di...

Page 74: ...sitivity 48 Perfusions Index 17 Pictograms 18 PIN code 44 Possible misapplications 8 Pulse tone volume 45 R Removal 7 Replacement Parts 70 S Safety 8 Screen 41 SD card 63 SD Card 63 Shipping inspection 20 Sleep Lab 42 SmartTone 49 Status message 59 Storage 20 Switching on 33 Symbol designation 5 System Alarms 55 System time 51 T Technical data 12 Total 62 Total alarm list 61 Transport 20 Trend dis...

Page 75: ...sat801 Pulse Oximeter Index 75 ...

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