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sat 805 Pulse Oximeter

Safety

2.1.1

Possible Misapplications

WARNING! Fire Hazard!

The pulse oximeter may not be used during nuclear magnetic resonance imaging tests. The

electrical current induced there can cause burns. This may affect the MRI image and the MRI

device may affect the accuracy of the Pulse Oximetry parameters and measurements.

–

This device is to be operated by qualified personnel only. This manual, all precautionary information

and specifications should be read before use.

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The pulse oximeter may not be used to monitor breathing (apnea monitor.). This may take place

only with special respiratory monitoring equipment.

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A pulse oximeter should be considered an early warning device. As a trend towards patient

hypoxemia is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely

understand the patient’s condition.

–

Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore

may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or
substitute for ECG based arrhythmia analysis.

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Explosion hazard. The pulse oximeter may not be used in a combustible atmosphere. This can

develop when working with flammable anesthetics, laughing gas, or other combustible gases and
liquids.

–

If an alarm condition (other than the exceptions listed herein) occurs while the alarm tone volume is

set to off, the only alarm indications will be visual displays and symbols related to the alarm
condition.

–

Do not use any extensions power cords or adapters of any type. The plug-in power supply must be

intact and undamaged.

–

The pulse oximeter may not be operated in a switchable power socket. Such a plug socket is

unsuitable for a secured power supply.

–

The pulse oximeter works with an optical measurement procedure and should not be operated near

to strong and/or direct light sources.

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Only use one sensor per measuring point to avoid interferences.

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Pay attention to a secured and fixed location of the sensors!

Содержание sat 805

Страница 1: ...llschaft für Homecare und Medizintechnik mbH Zum Pier 79 44536 Lünen Germany Tel 49 0 231 88 08 85 0 Fax 49 0 231 88 08 85 58 E Mail sales hum online de Internet www hum online de ID 3701405 Rev 1 0 21 01 2019 ...

Страница 2: ...sible Misapplications 12 2 2 User Responsibility 13 2 3 Possible Dangers from the Equipment 14 2 4 Users 15 2 5 Customer Service 15 3 Technical Data 16 3 1 Unit Data 16 3 2 Masimo Pulse Oximetry 17 3 3 Factory Default Settings 19 3 4 Life Times 19 4 Assembly 20 4 1 Displays and Controls 20 4 2 Connections 20 4 3 LC Display 21 4 4 Pictograms on the Device 22 4 5 Interfaces 24 4 5 1 Analogue Interfa...

Страница 3: ...ns Power Failure Alarm 31 6 4 Connections 32 6 4 1 Connecting the Patient Cable and Sensor 32 6 4 2 Disconnecting the Sensor 33 6 4 3 Disconnecting the Patient Cable from the Unit 34 6 5 Installing the Unit 34 6 6 Using Masimo Sensors 35 6 6 1 Selecting the correct Sensor 36 6 6 1 1 Adhesive Sensors 36 6 6 1 2 Reusable Sensors 37 6 6 1 3 Patient Cable 38 6 6 2 Expected lifetimes of patient cables ...

Страница 4: ...n 53 7 7 1 Screen options Screen 53 7 7 1 1 Contrast Contrast 53 7 7 1 2 Backlight Backlight 54 7 7 1 3 Menu Language Language 54 7 7 1 4 Access Permissions Home Mode 55 7 7 2 Acoustical Alarms Acoust Alarms 57 7 7 2 1 Pulse Tone Volume Volume Pulse 57 7 7 2 2 Alarm Tone Volume Volume Alarm 58 7 7 2 3 Alarm Silence Time Silence Time 59 7 7 3 Masimo Signal Processing Signalprocessing 60 7 7 3 1 Ave...

Страница 5: ...splay 70 7 10 Exporting the Data 71 8 Alarms 73 8 1 General 73 8 2 Alarm Categories 74 8 2 1 High Priority Alarms 74 8 2 1 1 SpO2 Alarm 75 8 2 1 2 Pulse Rate Alarm 75 8 2 1 3 Sensor Alarms 76 8 2 1 4 System Alarms 77 8 2 2 Medium Priority Alarms 79 8 2 3 Low Priority Alarms 80 8 3 Status message 81 8 4 Battery Alarms 82 8 4 1 Battery Alarm low priority 83 8 4 2 Battery Alarm medium priority 83 8 4...

Страница 6: ...Disinfecting the patient cable 91 10 3 Cleaning 92 10 3 1 Cleaning the Unit 92 10 3 2 Cleaning of Masimo Sensors 92 10 3 3 Cleaning of Patient Cables 93 10 4 Maintenance 93 10 4 1 Regular Check 94 10 4 2 User Check of Alarm Function 94 11 Accessories and Replacement Parts 96 11 1 Accessories 96 12 Advanced Information 97 12 1 Averaging Time 97 12 2 Alarm Signal Generation Delay 98 13 Index 99 ...

Страница 7: ...tion Important technical safety notices 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 WARNING Injury or Mortal Danger This symbol marks notices that if not observed can lead to health impairments in...

Страница 8: ...or based on the newest technical changes If you have question please contact the manufacturer We reserve the right to make technical changes on the product within the context of improving and advancing performance characteristics We warrant our sat 805 to be free from manufacturing defects in materials and workmanship for two years starting from the date of delivery Product warranties remain valid...

Страница 9: ...porting of the contents are not permitted without written permission from the manufacturer Offences are subject to compensation Additional rights remain reserved We reserve the right to exercise all rights relating to conditional patent rights This device is covered by one or more of the following U S Patents RE38 492 RE38 476 7 221 971 7 215 986 7 215 984 6 850 787 6 826 419 6 822 564 6 816 741 6...

Страница 10: ...l The unit contains batteries which are not allowed to be discarded into the domestic refuse Therefore rather than throw the batteries into the domestic refuse dispose of them instead at an appropriate collection site If the unit s end of usage stage has been reached it is to be disposed of according to the laws Alternatively the unit can be returned to the dealer who then takes over the professio...

Страница 11: ...to its structure and its configuration the unit can be used domestically in the clinical setting and in the sleep laboratory stationary and mobile inside and outside of these areas The pulse oximeter is considered to be an early warning system If a possible undersupply of a patient s oxygen is indicated a more exact investigation is immediately necessary ATTENTION Each use of the unit beyond that ...

Страница 12: ...optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis Explosion hazard The pulse oximeter may not be used in a combustible atmosphere This can develop when working with flammable anesthetics laughing gas or other combustible gases and liquids If an alarm co...

Страница 13: ...vels of COHb are suspected laboratory analysis co oximetry of a blood sample should be performed Elevated levels of Total Bilirubin may lead to inaccurate SpO2 measurements Severe anemia may cause erroneous SpO2 readings 2 2 User Responsibility This user manual information must be kept within direct proximity of the unit and must be available to those using the equipment at any time The unit may o...

Страница 14: ...may only take place by trained specialists Before any work on the unit remove it from the network connection Before each use always check network connection cables for damage CAUTION Danger from Rechargeable Batteries The unit contains rechargeable Lithium Ion batteries Do not throw batteries into a fire or expose them to high temperatures Risk of explosion exists With incorrect usage liquid could...

Страница 15: ...sed 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 2 5 Customer Service If assistance ...

Страница 16: ...l power supply Lithium Ion batteries 7 2 V mind 3 6 Ah Battery autonomy 20 hours guaranteed 24 hours typical Environmental Conditions Operation Temperature Humidity Air pressure 5 to 40 C 15 to 93 non condensing 600 mbar to 1060 mbar Environmental Conditions Storage Temperature Humidity Air pressure 25 to 70 C 15 to 93 non condensing 600 mbar to 1060 mbar Classification in accordance with MDD Medi...

Страница 17: ...d 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 in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion between ...

Страница 18: ...onitor 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...

Страница 19: ... low OFF Alarm filter Pulse high OFF SmartTone ON Artifact Filter OFF 3 4 Life Times Component Value sat 805 5 years Batteries 3 years Patient cable 17280 hours X CAL limited Pulse oximetry sensor reusable 8760 hours X CAL limited Pulse oximetry sensor not reusable 168 hours X CAL limited The Masimo X CAL feature will prevent the use of components with an error message after the abovementioned hou...

Страница 20: ...knob incl yellow red alarm LEDs 5 Connector for patient cable Fig 1 Display and Controls 4 2 Connections Connections in the rear panel 1 Alarm loud speaker 2 Interface connector nurse call 3 Interface connector analogue 4 AC adapter socket 5 USB 2 0 Fig 2 Rear Panel Connections in the left panel 1 Patient lead connection 2 SD Card slot Fig 3 Left Panel ...

Страница 21: ... 5 Actual battery capacity 6 Pulse frequency in beats per minute 1 min alarm limits high and low 7 AR symbol is displayed when the Artifact Filter is active 8 AL symbol is displayed when the ALarm filter is active 9 Alarm limits pulse frequency 10 Alarm tone mute symbol and remaining time in seconds if the audio alerts are temporarily suppressed if the audio alerts are switched off 11 Alarm limits...

Страница 22: ...icularly 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 calculated from the reflected infrared portion The Perfusion Index is a relative measure...

Страница 23: ... manufacture Notified Body TÜV Rheinland LGA Products GmbH Legitimate air pressure range for storage Legitimate air humidity range for storage Legitimate temperature range for storage Model Number Serial Number Applied part type BF IP 22 Protection against contact with fingers and medium sized solid foreign objects protection against slanty falling dripping water ...

Страница 24: ...ATTENTION To connect to the interface use only original manufactured parts Otherwise the unit could be damaged 4 5 1 Analogue Interface The analogue interface signals are output as follows Parameter Pin No Value Range Voltage Range Plethysmogram 2 0 255 0 2 5 volts Ground 3 SpO2 4 0 100 0 1 0 volts Pulse frequency 5 0 240 1 min 0 2 4 volts NOTICE The analogue voltages are constantly supplied to th...

Страница 25: ...e device the acoustic alarms still always sound on the external alarm interface Pin assignment for the external alarm interface is as follows Fig 6 External Alarm interface CAUTION Danger by Failure of the Alarm System With a failure of the alarm system there are NO alarm signals available 4 5 3 USB2 0 Interface The USB interface is for service and maintenance use only Pin1 Pin no Signal 3 Relay t...

Страница 26: ...Identification Nameplate The nameplate is located on the bottom side of the unit The following information can be found there Manufacturer Unit description Production year Serial number Power supply Type number Fig 7 Identification Nameplate ...

Страница 27: ... immediately after discovery Damage claims can only be processed during the valid time period for claim acceptance 5 2 Scope of Delivery Please check the contents of the package immediately following receipt If the items are missing please contact your medical equipment dealer immediately ATTENTION Never use other accessories than specified Scope of delivery 1 Pulse oximeter sat 805 2 Plug in powe...

Страница 28: ... Storage Only store the unit under the following conditions For shorter periods of storage store the device with batteries half charged For longer periods of storage without usage let the batteries getting removed Therefore please contact your medical device supplier Secure the unit before storage or turn OFF Do not store outside Store in dry dust free area Do not expose to aggressive media Preven...

Страница 29: ...all system components needed for a proper operation are available Please contact the manufacturer or your medical device supplier for help in commissioning in operation maintenance or any other way You can find the address of the manufacturer in Ch 2 5 The address of the supplier was handed over while briefing Furthermore contact the companies as stated above in case of an unexpected operating sta...

Страница 30: ...the unit connector 2 Plug the other end of the cable into an electric outlet Fig 9 Mains Power Adapter Plug 3 The green network LEDs 1 display NOTICE The green network LEDs only signal that the unit is supplied with electricity The LEDs do not show the unit s operating condition ON OFF 4 For charging the unit remain the unit plugged in for 6 hours with the unit switched off and for 10 hours when s...

Страница 31: ...edium priority is triggered Fig 11 Mains Power Failure Alarm 2 The mains power failure will generate a corresponding entry into the alarm list 3 After 30 seconds the alarm will be cancelled The unit is now in battery operation mode 4 If the mains power supply is re installed in the course of the a m 30 seconds the mains power alarm will be automatically reset NOTICE The Mains Power Failure conditi...

Страница 32: ...equired Masimo Sensor see chapter 6 6 3 Connect the sensor connector into the patient cable connector The plug only fits in one direction and noticeably snaps in NOTICE Some Masimo Sensors e g type DCSC already have an integrated patient cable In this case the connection to a separated patient cable is omitted Fig 13 Connect Patient Cable Fig 14 LNOP Sensor Connector Fig 15 LNCS Sensor Connector F...

Страница 33: ...unlocks the sensor plug 2 Remove the plug from the coupling 2 Fig 17 LNOP Sensor Coupling 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 RD SET Sensors 1 Pull firmly in the sensor connector to remove from the patient cable Fig 19 RD SET Sensor Coupling ...

Страница 34: ... Under normal circumstances the unit should be positioned on the night table next to the patient s bed WARNING Danger from the Cable in Patient Vicinity When positioning the unit secure the cable line to avoid strangulation of the patient WARNING 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 influen...

Страница 35: ...nly use approved Masimo sensors with the unit Use of other sensors can reduce the performance capacity of the unit and thus produce danger to the patient Tissue damage can be caused by incorrect application or use of a sensor for example by wrapping the sensor too tightly Inspect the sensor site as directed in the Instructions for Use to ensure skin integrity and correct positioning and adhesion o...

Страница 36: ...ildren and Adults 10 kg and 50 kg Ring or Middle Finger of the non dominant Hand HPO04 INF LNCS Inf L Small Children 3 kg 20 kg Great Toe or Thumb HPO04 NEO LNCS Neo Newborn 3 kg adults 40 kg Foot alternatively Back of the Hand HPO04 NEOPT LNCS NeoPt Neonatal Preterms 1 kg Foot alternatively Back of the Hand HPO05 ADT RD SET Adt Adults 30 kg Ring or Middle Finger of the non dominant Hand HPO05 PDT...

Страница 37: ...ger of the non dominant Hand HPO04 DCI LNCS DCI Children and Adults 30 kg Ring or Middle Finger of the non dominant Hand HPO04 DCIP LNCS DCIP Children and Adults 10 kg and 50 kg Ring or Middle Finger of the non dominant Hand HPO04 YI LNCS YI Children and Adults 1 kg 10 kg Ring or Middle Finger of the non dominant Hand 3 kg 10 kg Great Toe 3 kg Foot alternatively Back of the Hand HPO04 TCI LNCS TC ...

Страница 38: ...NCS Sensors HPO05 K PC05 RD SET MD14 05 Patient Cable 1 5 m for RD SET Sensors HPO05 K PC08 RD SET MD14 08 Patient Cable 2 4 m for RD SET Sensors HPO05 K PC12 RD SET MD14 12 Patient Cable 3 6 m for RD SET Sensors 6 6 2 Expected lifetimes of patient cables and sensors NOTICE X CAL or lifetime related alarms messages and information might not be present in all devices To confirm please check in the ...

Страница 39: ...ent use SpO2 Sensors without replaceable tape 168 hours 7 days 14 days 21 days Reusable SpO2 Sensors DCI DCIP YI TC I TF I and DBI 8760 hours 12 months 24 months 36 months Patient Cables 17520 hours 24 months 48 months 72 months 6 6 2 1 90 Lifetime or Near expiration message Sensor Cable Remaining time at 90 Single patient use SpO2 Sensors with Replaceable tape ca 34 hours Single patient use SpO2 ...

Страница 40: ... sensor near expiration 6 6 2 2 Life time exceeded If the life time of the accessories is reached during monitoring operation the technical message Service life reached is output Exceeding this threshold triggers a further period of time the so called extension phase This is 12 hours for single patient adhesive sensors and 72 hours for reusable sensors In this phase the accessories can still be us...

Страница 41: ...d together with this as a high priority alarm Fig 27 Cable expired expiration High priority alarm Cable expired Sensor not on patient Fig 28 Sensor expired High priority alarm Sensor expired Sensor not on patient Fig 29 Adh Sensor expired High priority alarm Adh Sensor expired Sensor not on patient Fig 25 X CAL Sensor expired Technical message X CAL Sensor expired Fig 26 X CAL Adh sensor expired T...

Страница 42: ... is impossible Fig 30 Defective sensor High priority alarm Defective sensor beyond lifetime 6 7 Using the Interfaces The interfaces on the device may be operated and installed by trained personnel only Connecting the analog or nurse call interface via the interface connector is only allowed upon instruction of these persons WARNING Danger by improper Application of the Interface If non specified d...

Страница 43: ...tion 7 2 1 Using the Trim Knob Operation of the menu by the trim knob 1 Turning clockwise up page up and increase values 2 Turning counter clockwise down page down and decrease values 3 Short push 1 sec confirm setting or activate acoustical alarm mute function active alarm 4 Long push 1 sec enable disable acoustical alarm mute function independent of active alarm Fig 31 Trim Knob NOTICE If you do...

Страница 44: ... in some cases it is necessary to select several menu items one after the other before the final setting can be made The menu structure is as follows Level 1 Level 2 Level 3 Remark Pleth Display without pleth Configuration of the LC display compressed stretched Alarm limits Setting the alarm limits and alarm filter parameters Data Vital alarm list Alarm lists Total alarm list Trend On screen data ...

Страница 45: ...al alarms Silence Time Signal process Algorithm mode Setting of pulse oximetry parameters Averaging time SmartTone Artifact filter Screen Contrast Adjustment of the LC screen options Backlight Language Home mode Nurse call Configuration of the external alarm interface Analogue out Calibration signals Clock Setting the system time Product Info Overview of the device settings ...

Страница 46: ...responding error message is displayed in the display The unit can and may not be used on patients ATTENTION Defective Alarm Loudspeaker If the alarm loudspeaker is defective a replacement signal generator is activated internally This does not take over the full functionality of the alarm loudspeaker volume tone sequences The device must then not be used on the patient 4 After this the Normal Displ...

Страница 47: ...vice will not enter the standard mode but will be switched off automatically 5 Now the unit is operational Fig 36 Silent Alarm Tone 7 4 Turning the Unit off The turn off process is designed so that turning it off accidentally can possibly be avoided After turning off the unit all previously entered values and configurations are preserved Except for the settings Alarm tone loudness 0 OFF and algori...

Страница 48: ... in charge of the treatment NOTICE Until the modified alarm limit value has been accepted the most recently stored value remains in force If the alarm limit modification procedure is interrupted or cancelled this value persists The saved limits remain also after a complete loss of the voltage If implausible alarm limits are set e g the lower limit value is greater than the higher value the device ...

Страница 49: ...per pulse rate alarm limit or select Pulse lo for setting the lower pulse rate alarm limit 3 Select the alarm limits to be changed by pressing the trim knob 4 Set the new value by turning the trim knob 5 Confirm the new value by pressing the trim knob 6 Set other values if needed 7 Leave the menu with Return 8 Confirm all new values by confirming the safety question Accept Y N Fig 39 Alarm Limits ...

Страница 50: ...mum the occurence of an alarm 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 f...

Страница 51: ...m the new value by pressing the trim knob 6 Set other values if needed 7 Leave the menu with Return 8 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 AL in the lower right area of the display Fig 43 Modifying the Alarm Filter Fig 44 Confirming the Settings Fig 45 Status Symbol AL ...

Страница 52: ... stretched 2 Compressed normalized plethysmogram Fig 47 Plethysmogram compressed 3 Big numbers only without plethysmogram Fig 48 Number Display For configuration of the display 1 Starting from the main menu select Pleth display 2 Select the display mode by turning the trim knob 3 Confirm the setting by pressing the trim knob 4 Return to the main menu by selecting Return Fig 49 Plethysmogram Displa...

Страница 53: ...ting of the LC display The contrast can be adjusted between values of 1 and 10 NOTICE The contrast setting will depend on external environmental conditions such as the prevailing amount of light and the angle when reading the device 1 Starting from the main menu call Configuration Screen Contrast 2 Adjust the contrast by turning the trim knob The contrast is represented by a figure between 1 und 1...

Страница 54: ...trim knob NOTICE The changes made will be shown in the settings 3 Confirm the selection by pressing the trim knob Fig 52 Backlight 7 7 1 3 Menu Language Language This function sets the menu language 1 Starting from the main menu call Configuration Screen Language 2 Select the desired language by turning the trim knob NOTICE The changes made will be shown in the settings 3 Confirm the selection by ...

Страница 55: ...s Permissions The HomeCare mode ON access protects the inexperienced user from modifying important monitoring parameters These parameters are invisible The HomeCare mode OFF access allows users to set all the configuration parameters Access Permissions HomeCare ON HomeCare OFF Pleth Display Alarm Limits Alarm Filter Vital Alarm List Total Alarm List Trend Memory Config Erase Memory Volume Puls Vol...

Страница 56: ...uage Nurse Call Analog out Clock Product Info not allowed allowed Setting the Access Permission 1 Starting from the main menu call Configuration Screen Home Mode ON OFF 2 Enter the four digit pin code for the respective access permission NOTICE The pin code is located in a separate document In case call the manufacturer 3 Select the first digit with the trim knob Fig 55 PIN Code Entry ...

Страница 57: ...usted Pulse tone volume Volume Pulse Alarm tone volume Volume Alarm Alarm tone mute time Silence Time Fig 57 Acoustical Alarm 7 7 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 gr...

Страница 58: ...splay 7 7 2 2 Alarm Tone Volume Volume Alarm 1 Starting from the main menu call Configuration Acoust Alarm Volume Alarm 2 Adjust the alarm tone volume with the trim knob between OFF and loud 10 NOTICE Every incremental change emits the actual volume strength once 3 Confirm this setting by pressing the trim knob NOTICE If you select the OFF setting the display shows the permanent alarm silence symb...

Страница 59: ...ble 7 7 2 3 Alarm Silence Time Silence Time The alarm signal mute time displays the duration of the mute signal if the alarm signal mute time has been set and acknowledged After expiration of this time the sound alarm is activated again if the acknowledged alarm condition still exists The alarm signal mute time can be set between 30 60 90 and 120 seconds 1 Starting from the main menu call Configur...

Страница 60: ...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 61 Masimo Signal Processing 7 7 3 1 Averaging Time Averaging time The averaging time indicates the duration with which from several o...

Страница 61: ...he signal distribution i e display FastSat can be especially useful for incubations or for polysomnography where a high level of reliability in the saturation recognition process is desirable FastSat is also able to stream the oxygen saturation changes from breath to breath 7 7 3 1 Perfusion Sensitivity Algorithm mode The perfusion sensitivity can be set between Normal Norm perfus Maximum resp hig...

Страница 62: ...d It is useful for patients that are at particular risk of the sensor becoming detached pediatric combative etc How does APOD compare to Max or Normal sensitivity APOD is the least sensitive in picking up a reading on patients with low perfusion Normal Sensitivity provides the best combination of sensitivity and probe off detection performance and is recommended for the majority of patients Max Se...

Страница 63: ...N 7 7 3 4 Artifact Filter Artifact Filter To eliminate short term and therefore irrelevant losses of the pulse signal an artifact filter can be applied by selecting ON or OFF This filter is applied to the following sensor related alarms only No Sensor Connected Defective Sensor Interference Detected Sensor Off Patient Too Much Ambient Light Unrecognized Sensor The artifact filter rejects sporadic ...

Страница 64: ...odified with the trim knob 3 Adjust the number with the trim knob 4 Repeat this sequence for each number to be modified 5 Confirm this setting with Accept NOTICE The clock time does not 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 press the trim knob to accept the time and date Fig 64 Setting the System ...

Страница 65: ... In the Norm close setting the contact is permanently open as long as the alarm condition continues Before connecting a remote alarm device you must select the Remote alarm setting This gives a clocked transmission of coded alarm information from the device to the remote alarm device 1 Starting from the main menu call Configuration Nurse call 2 Select the desired setting using the trim knob Norm o...

Страница 66: ...On the interface the analog voltages for 0 SpO2 0 1 min pulse rate and the baseline for the plethysmogram are output 100 On the interface the analog voltages for 100 SpO2 240 1 min pulse rate and the full scale deflection of the plethysmogram are output Steps In this mode voltage steps are output starting at 0 volts and ending at 1 0 volt rising by incremental steps of 0 1 volt per second 1 Starti...

Страница 67: ...s of continuous monitoring with a maximum of 4000 alarm list entries Though only the last 500 are visible and displayed on the screen NOTICE Even in the case of an entire voltage loss the alarm lists remain unchanged Also in the state of ALARM VOLUME 0 OFF all alarms are logged On the device you have the option of analyzing the stored data in the form of lists and alarm event graphics a list of al...

Страница 68: ...hrough the list Turn the encoder clockwise to show a more recent alarm i e higher alarm numbers turn the encoder counter clockwise to show an older alarm i e lower alarm numbers 3 Leave the list by confirming Return Fig 70 Vital Alarm List 7 8 2 Total Alarm List Total alarm list Selecting Total alarm list displays a list of all the alarm events vital and technical alarms as a table on the display ...

Страница 69: ...alarm i e higher alarm numbers turn the encoder counter clockwise to show an older alarm i e lower alarm numbers 3 Leave the list by confirming Return 7 8 3 Alarm Details 1 Call the Alarm list 2 Mark an alarm entry and select it by pressing the trim knob In the window following information is displayed Start date Start time Alarm duration Type of alarm here SpO2 hi Alarm limits Extreme value or ty...

Страница 70: ...wn as a trace SpO2 or pulse or both simultaneously over different time as 12 8 6 4 2 hours 60 30 10 4 2 minutes 7 9 1 Trend Display 1 Starting from the main menu call Data Trend 2 Select the time scale 2 minutes till 12 hours 3 Select the display mode SpO2 Pulse or both The most recent data are displayed in the required format 4 Turn the trim knob clockwise to move the pointer to later times and c...

Страница 71: ...lysis the stored data can be exported to a SD card WARNING Whilst the data is being exported there is no monitoring and therefore no alarms should the patient be in a life threatening situation NOTICE The pulse oximeter only accepts empty erased SD cards All other cards will be refused with an error message Fig 74 Card not readable 1 Switch off the device 2 With the angled edge to the top and the ...

Страница 72: ...ssage File has been saved successful Please take the Memory Card out is displayed When the data has been successfully written to the SD card the data memory in the device is automatically deleted NOTICE If the transmission is interrupted or a fault occurs the pulse oximeter outputs an error message No data is stored on the SD card in this event 4 Take the SD card out The data on the SD card can th...

Страница 73: ...he patient s vital parameters using other methods and then investigate whether the device is functioning WARNING Danger by quiet alarm tones Please ensure that the openings of the loudspeaker are not covered in any way Inaccurate measurements can be caused by Incorrect sensor connection or incorrectly selected Masimo sensor A significant proportion of dysfunctional hemoglobin e g carboxyhemoglobin...

Страница 74: ...from low blood pressure severe vasoconstriction and or anaemia or hypothermia The artery is obstructed close to the sensor The patient is in shock or cardiac arrest The fingernail is varnished 8 2 Alarm Categories There are three alarm categories High priority alarms require immediate user intervention in order to avoid possible damage to the patient Medium priority alarms show a technical problem...

Страница 75: ... Acoustic alarm OFF has been selected in the configuration menu then an alarm does not sound Only the visual signals can notify the responsible user of the presence of an alarm condition 8 2 1 1 SpO2 Alarm Status Line Message Message in the LC Display Cause SpO2 flashing SpO2 values Oxygen saturation exceeds the set alarm limit SpO2 flashing SpO2 value Oxygen saturation falls below the set alarm l...

Страница 76: ...ed to the unit Check patient cable connection between unit and sensor If needed replace the patient cable Sensor off patient The sensor is connected to the unit the unit is on but no patient can be recognized Position the sensor correctly Defective sensor The device has determined that the sensor does not function at all or only to a limited extent Replace the sensor with a new Masimo sensor Unrec...

Страница 77: ...in the accessories or following a no data alarm after the next 120 seconds this alarm is triggered Check cable and sensor replace if necessary or Clean the sensor Reposition the sensor Exchange the sensor or and patient cable with a new one Check sensor The system has detected a possible fault in the accessories Check cable and sensor replace if necessary 8 2 1 4 System Alarms WARNING No Monitorin...

Страница 78: ...e is below a level that guarantees reliable operation SYST ALARM MS FIFO An error has arisen in the Masimo input data memory SYST ALARM MS timeout The Masimo circuit board has not responded to several queries or does not provide data for more than 60 seconds SYST ALARM MS comm The Masimo data transfer has a permanent defect SYST ALARM MS error The Masimo circuit board has reported an irreparable d...

Страница 79: ...iority Alarms With alarms of mid level priority a correct signal reception cannot be guaranteed At times the patient will not be monitored correctly for the duration of the alarm The cause of the alarm must be corrected as soon as possible Medium priority alarms display technical problems and require quick user intervention With medium priority alarms the medium priority alarm tone sounds the yell...

Страница 80: ...erly After 60 seconds a system alarm is triggered Clean the sensor Reposition the sensor Exchange the sensor or and patient cable with a new one Battery depleted Remaining operation time of 15 minutes or less Recharge battery 8 2 3 Low Priority Alarms With a low priority alarm the audio sound of low priority is heard the yellow alarm LEDs 1 light and the status line message appears NOTICE With low...

Страница 81: ...itoring situation Status Line Message Description Solution Low perfusion The unit has determined insufficient circulation for reliable determination of oxygen saturation values Remove the sensor and position at a different place Signal IQ too low The signal strength for signal reliability is too low Remove the sensor and position at a different place Pulse search At too low perfusion or during the...

Страница 82: ...or insufficient battery capacity and reminds the user in good time to connect the pulse oximeter again to the mains supply and to recharge the internal battery There are three stages in battery alarm management Battery alarm low priority Battery alarm medium priority System battery alarm high priority WARNING Insufficient Monitoring With continued battery alarm act quickly Monitoring of the patien...

Страница 83: ...ty Status Line Message Description Solution SYST ALARM Bat low Battery capacity is so low that reliable monitoring can no longer be guaranteed Signal processing and the monitoring function are disabled Recharge battery An empty battery icon will be displayed 8 5 Combination of Alarms of Different Priorities With overlapping different alarm conditions the latest alarm with the highest priority is a...

Страница 84: ...move unit from patient 3 Remove external interfaces 4 Correct failure with help of Table below WARNING Danger to the Patient Never use a malfunctioning unit List of possible Malfunctions Error Messages Message Cause Solution Unit cannot be turned on Batteries are empty Recharge batteries connect unit to electricity Should function not occur even with a networked connection inform medical device su...

Страница 85: ... has determined the sensor does not work or only in limited capacity Exchange the sensor with a Masimo Sensor Status Line Message Defective adh sensor The device has determined that the sensor does not function at all or only to a limited extent Replace the sensor with a new one Status Line Message Defective patient cable The device has determined that the patient cable does not function at all or...

Страница 86: ...trong 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 Status Line Message Signal IQ too low The signal strength for signal reliability is too low Remove the sensor and position at a different place Status Line Message MS Comm lost data Data transfer error The device has registered this fact and has automat...

Страница 87: ...ck sensor connection The system has detected a possible fault in the accessories Check connection between patient cable and sensor If needed replace sensor and or cable Status Line Message Check cable and sensor The system has detected a possible fault in the accessories Check connection between patient cable and sensor If needed replace sensor and or cable Status Line Message No adh sensor connec...

Страница 88: ...ensor not approved for this system Use approved Masimo accessories only Status Line Message Incompatible sensor The unit has discovered a sensor not approved for this system Use approved Masimo accessories only Status Line Message Incompatible cable The unit has discovered a patient cable not approved for this system Use approved Masimo accessories only ...

Страница 89: ...ys In the clinic Dispose of disposable sensors Weekly In the clinic Clean and disinfect sat 805 patient cable Weekly outside of the hospital Clean sat 805 Every 4 Weeks outside of the hospital Dispose of disposable sensors At change of patient Clean and disinfect sat 805 included carrying bag AC adapter patient cable and reusable sensors At change of patient Dispose of disposable sensors After ser...

Страница 90: ...ication instructions of the disinfectant manufacturer must be followed Disinfection takes place as part of a surface wipe disinfection For this purpose the disinfectant is distributed on a disposable wipe and the surface of the pulse oximeter to be disinfected is wiped off using the cross method 2 x longitudinal 2 x transverse After the manufacturer and disinfectant dependent exposure time further...

Страница 91: ...N Danger to cable functionality Do not use undiluted bleach 15 5 25 sodium hypochlorite or any cleaning solution other than those recommended here because permanent damage to the sensor may occur Do not immerse the cable or connector in any liquid solution Do not sterilize by irradiation steam autoclave or ethylene oxide Disinfect the patient cable as follows 1 Disconnect the connection from both ...

Страница 92: ...erilization 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 10 3 2 Cleaning of Masimo Sensors The re usable Masimo sensors are to be cleaned as follows 1 Disconnect from the patient cable and also ...

Страница 93: ...the unit repair it or perform maintenance yourself Corrections of defects repairs or any maintenance should be done exclusively by HUM Gesellschaft für Homecare und Medizintechnik mbH or by a HUM Gesellschaft für Homecare und Medizintechnik mbH authorized medical device supplier NOTICE A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter NOTICE If...

Страница 94: ...imit at 5 below the displayed value The new alarm value for the upper oxygen saturation limit will display A high SpO2 alarm will occur The red LED will blink and the high priority alarm will sound 3 Reset the upper alarm limit to 100 The new alarm value will be accepted The alarm goes silent 4 Set the lower oxygen saturation alarm limit at 98 5 Set the lower oxygen saturation alar m li mit at 98 ...

Страница 95: ...imit 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 The alarm goes silent The red LED blinks and a new high priority alarm will sound 10 Remove patient cable from the unit The sensor alarm will sound The red LED blinks and a new high priority alarm will sound 11 This completes the check of the unit s alarm functio...

Страница 96: ...ts are void without prior notice by the use of unapproved accessories or replacement parts 11 1 Accessories Only use original supply parts from the manufacturer Order No Item HPO02 805 KAF Remote alarm nurse call interface cable HPO02 805 H Mounting bracket for infusion poles and rail systems HPO02 805 T Carrying case HPO02 805 816 NTEU Euro power supply HPO02 SW SATVIEW BV Software satView basic ...

Страница 97: ...urve 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 ...

Страница 98: ... 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 ...

Страница 99: ...arm tone volume 58 Alarms 73 Analogue interface 24 66 APOD 62 Artifact Filter 63 Assembly 20 Averaging time 60 97 B Backlight 54 Batteries 14 Battery Alarm 82 C Charging the batteries 29 Cleaning 89 Clinic 55 Clock 64 Combination of Alarms 83 Connecting the Patient cable 34 Connections 32 Connections 20 Contrast 53 Control 43 Controls 20 Copyright protection 9 Customer Service 15 D Dangers 14 Data...

Страница 100: ...times of patient cables and sensors 38 Loss of pulse signal 74 Low priority alarms 80 Low level alarm 81 M Mains operation 29 Mains power failure alarm 31 Maintenance 93 Malfunctions 84 Masimo Signal Processing 60 Masimo Sensors 35 Medium priority alarms 79 Menu 43 N Normal Display 46 Nurse call 65 Nurse Call alarm 25 O Operating instructions 7 P Packaging 28 Perf Mode 61 Perfusion Sensitivity 61 ...

Страница 101: ...martTone 63 SpO2 Alarm 75 Status message 81 Storage 28 Switching on 45 Symbol designation 7 System Alarms 77 System time 64 T Technical data 16 Total 70 Total alarm list 68 Transport 27 Trend display 70 Turning off 47 U USB2 0 Interface 25 User Check of Alarm Function 94 User responsibility 13 Users 15 V Vital alarm list 68 W Warranty 8 X X CAL 38 ...

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