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D 8.4.1.20 O

matic User Manual - IFU

Appendix C

–

Accessories

Warning

Use of any other accessories than specified here, may

inflict serious injuries to the patient and/or damage the
device.

Power supply

Model: Mean Well GEM12I12

Input: 100-240VAC, 50/60 Hz, 0.4-0.2A

Output: 12V, 1A, 12W max.

Sensors

Pulse oximeter sensors are applied parts for the O

matic PRO 100.

Refer to their instructions for use for further information.
Use only Nonin Purelight pulse oximetry sensors.

Caution

The accuracy of the SpO

measurement may be affected

if the total sensor length (including extension cables) is
greater than 3 meters.

6000CA

–

Cloth adult box

6000CI

–

Cloth infant box

6000CN

–

Cloth neonatal box

6000CP

–

Cloth pediatric box

7000A

–

Flexi-Form III adult disposable box

7000D

–

Flexi-Form III assortment (4-A,2-I,2-N, 2-P)

7000I

–

Flexi-Form III infant disposable box

7000N

–

Flexi-Form III neonatal disposable box

Содержание OMC PC-100

Страница 1: ...2022 6 09 ...

Страница 2: ...ent to device 25 4 Treatment and Operation 33 4 1 Treatment modes 33 4 2 Patient assessment 35 4 3 Critical profiles 40 4 4 Walking tests 43 4 5 Shutdown 52 5 Warnings and Alarms 53 5 1 Alarm level indicators 53 5 2 Alarm zones 53 5 3 Possible alarm events 58 5 4 Alarm priorities 58 6 Electromagnetic Emissions and Immunities 59 6 1 Emissions compliance class and group 59 6 2 Immunity test levels 5...

Страница 3: ...in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment To avoid adverse events to the patient due to electromagnetic distur...

Страница 4: ...y the O2matic PRO 100 b Refer to the applicable sensor instructions for use for additional warnings and cautions c Regularly check the battery indicator If lit See section 7 3 for battery instructions d O2matic PRO 100 is only to be used with pure oxygen e Use of this equipment adjacent to or stacked with other equipment should be voided because it could result in improper operation If such use is...

Страница 5: ...tions a Do not place O2matic PRO 100 in a corner as it can be difficult to connect and disconnect accessories b The accuracy of the SpO2 measurement may be affected if the total sensor length including extension cables is greater than 3 meters c Pulse oximetry sensors may have reading troubles when used on patients with cold extremities due to reduced blood circulation For more information please ...

Страница 6: ...rent 12 VDC Manufacturer 0123 CE mark Made in compliance with all relevant directives Manufacturing date Serial number Do not use if the package is damaged Bell can be temporarily cancelled Not for general waste For use in oxygen rich environtm ent Alternating current Type BF Applied part Storage Temperature limits Standby ...

Страница 7: ...ors and safety O2matic PRO 100 should only be used by medical staff with basic experience in the use of pulse oximeters and treatment of patients in need of oxygen therapy It is recommended that each hospital appoints administrators responsible for setting up the device metadata i e standard profiles and alarm delays These should normally be physicians The O2matic PRO 100 has a failsafe rechargeab...

Страница 8: ... but also to select enter undo or go back a level as well as to increase or decrease values This is possible due to the dynamic functionality that is built in so that the function descriptions on the screen change based on the marker position Navigation buttons are physically lid when active and having a function in the active screen If the device is not interacted with it will eventually display ...

Страница 9: ...treatment the O2matic PRO 100 must be installed and setup accordingly as described in the following 2 1 Overview Figure 1 O2matic PRO 100 from the front Front Buttons A Standby E Battery indicator B Home F Manual Automatic Mode C Power warning G Mute alarms D Navigation A B C D E F G Handle ...

Страница 10: ...00 from behind Back Bottom Buttons H Pulse oximeter connection L Power switch I USB connection hatch M Power connection J Oxygen output connection N Oxygen input connection K Slider O Battery ventilation hatch Figure 3 Bottom of O2matic PRO 100 K O K L M J I H N ...

Страница 11: ...r safety reasons the connector is a screw lock mechanism Warning Only use the AC power adaptor provided by O2matic Any other power supply may interfere with the proper operation of the device g Connect the oxygen hose to the source of oxygen in the wall or an oxygen cylinder Then connect oxygen hose to the oxygen inlet of the O2matic PRO 100 Warning O2matic PRO 100 is only to be used with pure oxy...

Страница 12: ...no signal To mute the alarm press the Mute button G and the alarm will be muted for 2 minutes The light in the button is lid to indicate that it is muted Note Audible alarms are disabled in menus O2matic PRO 100 returns back to home screen after 1 minute of inactivity Note If above steps have been followed correctly and there is no visible home screen see the Service and Support section Note O2mat...

Страница 13: ... 8 4 1 20 O2matic User Manual IFU 13 2 3 Setting up the device All setup functionality in The O2matic PRO 100 are gathered in the Admin Menu From the Home Screen press to enter the Admin Menu shown below ...

Страница 14: ...D 8 4 1 20 O2matic User Manual IFU 14 Figure 5 O2matic PRO 100 Admin menu Setting up a new profile ...

Страница 15: ...min and select Profiles 2 Move to New Profile and select Create 3 Enter the profile name by using the and buttons When finished press the left arrow twice to save the name 4 Navigate to the desired parameters and adjust them as needed 5 Return to home screen by pressing B ...

Страница 16: ...D 8 4 1 20 O2matic User Manual IFU 16 ...

Страница 17: ...he O2matic PRO 100 has built in input validation to protect against unintended user input See appendix A for a list of input ranges Editing an existing profile 1 From the home screen select Admin and choose Profiles 2 Move to the desired profile and press Select 3 Navigate to the desired parameters and adjust them as needed 4 Save the adjustment Return to home screen by pressing B ...

Страница 18: ...D 8 4 1 20 O2matic User Manual IFU 18 ...

Страница 19: ...ed to increase comfort for the patient See appendix A for further info The O2matic PRO 100 has built in alarms and warnings that indicate the patient s health status Warnings are issued when the patient s SpO2 moves slightly outside desired level without being critical 2 4 Importing settings If you have multiple O2matic PRO 100 devices and you want a specific set of settings on all the devices thi...

Страница 20: ...on about the physical tool visit www o2matic com Warning The exported files should only be edited by an administrator that have extensive knowledge of the device Ignoring this can result in dangerous situations for the patient To import settings or profiles a Remove the screws of the USB hatch b Connect your device to a computer laptop via a USB 1 0 2 0 cable with Type A to Type B connectors c Ent...

Страница 21: ...ngs c Select Security d Select Set PIN default is 1111 e Input the old USB pin f Press Submit g Input the new USB pin h Press Submit Note It is recommended to change the default USB pin code when installing the device Resetting It is possible to reset the USB pin code if it is lost It is also possible to reset the device to factory defaults This will bring back all factory default profiles and set...

Страница 22: ...code is different for each machine If it is lost contact your local distributor To reset the USB pin code i Enter the admin menu j Select Settings k Select Security l Select Reset USB pin m Input the master pin code n Press Submit To reset to factory changes o Enter the admin menu p Select Reset q Input USB pin code r Press Submit ...

Страница 23: ...de see section 4 1 Thus the device is already in treatment mode and an alarm will start immediately if there is no signal from a pulse oximeter sensor To mute the alarm press G and the alarm will be muted for 2 minutes The button is lid to indicate that it is muted Entering any menu will also mute the alarms Upon startup the device resumes in the latest selected profile If the device was switched ...

Страница 24: ...D 8 4 1 20 O2matic User Manual IFU 24 ...

Страница 25: ...matic User Manual IFU 25 Figures 9 O2matic PRO 100 Home Screen 3 1 Assign a new patient to device a To assign a new patient to the device enter the Patient menu From the B screen Select Patient b Select New patient ...

Страница 26: ...D 8 4 1 20 O2matic User Manual IFU 26 ...

Страница 27: ...D 8 4 1 20 O2matic User Manual IFU 27 ...

Страница 28: ...D 8 4 1 20 O2matic User Manual IFU 28 ...

Страница 29: ...D 8 4 1 20 O2matic User Manual IFU 29 ...

Страница 30: ...a e seen below c Change the patient ID This can be done either by incrementing the patient ID by 1 OR by typing a specific patient ID to accommodate for a hospitals existing ID system Selecting Accept to increment patient ID by 1 OR Select Edit and use and buttons to manually enter desired ID You can select Clear to clear the patient ID if needed ...

Страница 31: ...und a lot thus more suited for a higher delay e Select a profile Profiles are a set of parameters tied together to avoid repetitive patient setups Standard profiles can be set up in the administrator menu and selected in the patient menu However the active profile can also be customized if needed The actual active profile is stated at the top of the screen Note Table A 4 in appendix A shows defaul...

Страница 32: ... device NOTE It may take up to 10 seconds before a clear signal from the pulse oximetry sensor is established NOTE Nail polish can cause impaired reading functionality of the pulse oximetry sensor Warning Never smoke during treatment This can inflict serious injuries Warning Never use any flammable products on the patient as this can cause serious injuries ...

Страница 33: ...he O2matic mode the O2matic PRO 100 device is automatically weaning the patient down from oxygen by giving the optimal oxygen flow necessary to the patient within the defined SpO2 interval Upon slight exceedance of the interval O2matic PRO 100 triggers a warning by changing the font to yellow and adjusting accordingly Upon a longer or steeper exceedance of the lower interval O2matic PRO 100 trigge...

Страница 34: ...hen the oxygen flow exceeds 15 liters min the flows inaccuracy can be around 2 liters min When increasing and decreasing the oxygen flow in the manual mode the incrementation rate changes to match the flow range Flow range Increments 0 10 l min 0 5 l min 10 15 l min 1 l min 15 20 l min 5 l min ...

Страница 35: ...atic PRO 100 has two distinct information screens to support better patient assessment From the B screen use and to cycle through them Trend screen The trend Info Screen shows charts related to the pulse SpO2 and oxygen dosage It is possible to zoom in and out on the chart to view trends from the last 12 minutes last 24 hours with and ...

Страница 36: ...D 8 4 1 20 O2matic User Manual IFU 36 ...

Страница 37: ...IFU 37 Figure 13 O2matic PRO 100 trend screen last hour Legends on screen Legends are illustrating either if a reboot of the device has occurred the profiled has been changed modified or a new patient has been paired with the device ...

Страница 38: ...es that the device has been rebooted or turned off and on The dotted vertical line indicates that the patient has been altered or changed The downward facing triangle indicates that the profile has been altered or changed to another profile Figure 15 Extract from figure 14 focusing on the legends Info screen The Info screen shows average SpO2 O2 and pulse rate numbers for the last 24 hours as well...

Страница 39: ...D 8 4 1 20 O2matic User Manual IFU 39 screen the lowest O2 supply of 1 liter a minute occurred at T 00 18 that is 18 minutes ago ...

Страница 40: ...ient profile is 80 A profile with a SpO2 value below 85 is termed a Critical Profile When the user edits a SpO2 value below 85 and try to select the value the user is prompted for a decision with SpO2 outside safe range If confirmed the name of the profile will appear in an orange font and can go below 85 but not under 80 If cancelled the value stays at 85 ...

Страница 41: ...D 8 4 1 20 O2matic User Manual IFU 41 Figure 17 SpO2 outside safe range prompt ...

Страница 42: ... for a decision Chosen profile is risky Continue Figure 818 Critical Profile prompt If confirmed the Active Profile name will appear in orange font on the Home screen The user is also prompted in the same way when the device is turned on with a Critical Profile set from before the device was turned off ...

Страница 43: ... screen and it becomes a Critical Profile then the name will still appear in orange but keep its profile name 4 4 Walking tests The O2matic PRO 100 device can perform both pre defined Walking Tests and user defined tests A log file of the tests performed are stored on the device Test results can be seen on the screen or reviewed by extracting logs ...

Страница 44: ...l Shuttle Walk Test ISWT The Endurance Shuttle Walk Test ESWT Each of these tests can be customised by the user It is also possible for the user to create additional tests see chapter 7 2 Running a test A walking tests consists of three phases Warm up shown as START IN Actual test shown as test name and TIME REMAINING Recovery shown as RECOVERY To see a 6 minute walking test 1 From the Home Screen...

Страница 45: ...D 8 4 1 20 O2matic User Manual IFU 45 Figure 20 Test Selection When a test has been selected the Test Setup Screen appears and the test can be customized by the user ...

Страница 46: ...on For a list of factory pre set profiles see table A5 in Appendix A To start the test place the cursor on Start Test in the top and press Select with the right arrow button on the device Now the test will start with the first phase warm up and the screen returns to the Home Screen with a countdown in the left bottom corner displaying the remaining warm up time ...

Страница 47: ...down The device beeps twice The 12 minutes 12M Trend Graph resets Test log begin recording The Active Profile change to the one used in the test profile The pre defined test shows WALKING in the top middle of the screen Note If the User has changed a value from the pre defined test profile which is actively used the profile name will turn yellow while the test is running to indicate that the test ...

Страница 48: ... should be made ready to resume normal treatment with the previous patient profile and the following will happen The device beeps twice Test log finishes recording The TIME LEFT countdown is replaced with RECOVERY When the RECOVERY countdown concludes the device returns to the previous active profile Caution Always stay with the patient during recovery to verify patient status upon resuming normal...

Страница 49: ... user is then prompted to either Cancel continue test or Confirm to stop the test The completed part of the test is still logged even if the test gets cancelled Note When a running test is cancelled the RECOVERY period is also cancelled and the previous Active Profile resumes right away Appropriate setup The following figures show an appropriate setup for performing tests involving walking as an e...

Страница 50: ...D 8 4 1 20 O2matic User Manual IFU 50 Figure 24 Appropriate setup side view Note Check how oxygen bottle and hoses are placed to avoid the wheels or the patient s legs being entangled ...

Страница 51: ...rement of the pre defined tests dictates that they can and may be performed on battery power only If the battery reaches a Low Battery charge state during the test a high intensity audio alarm will begin and Battery Fail will blink in a red font on the screen If this state occurs stop the test and re attach the device to external power at once Caution The device must be fixed securely using approp...

Страница 52: ...matic PRO 100 will treat this as power failure and turn on the battery failsafe mode and trigger an alarm NOTE It is possible to shut down the device by holding A down for 8 seconds This is not the intended shutdown but instead a forced shutdown mainly used for service situations A forced shut down will trigger an alarm that can only be disengaged by turning the device on and shutting it off in th...

Страница 53: ...ic PRO 100 is designed so that audible alarms can be detected by the operator from up to 10 meters away NOTE When navigating in menus the device still operates however alarms are muted Upon no operator activity for 60 seconds the home screen will reappear and the alarm will sound if triggered 5 1 Alarm level indicators Type Visual indications Audible Audio Alarm Signal Priority Audible indications...

Страница 54: ...and prioritization of these are described in section 5 4 If the device is not on external provided power the Battery Mode turns on the top and bottom of the screen now show a red bar and a warning pop up appears on the screen Below this zone there is a zone for the check status indication See the section 5 3 for further information on possible alarm events and a description of these Figure 26 O2ma...

Страница 55: ...igure 26 three alarms are present Flow Error alarm Pulse alarm and SpO2 alarm Figure 27 O2matic PRO 100 alarm zones 2 Figure 27 show Battery Mode alarm pop up and red top and bottom A Sensor Error No Pulse Oximeter input signal is also present ...

Страница 56: ... Pulse Pulse higher than defined Verify patient condition Pulse Pulse higher than 200 BPM Pulse Pulse lower than 40 BPM Signal No signal No signal from oximeter for less than 300 secs adjustable Readjust the sensor on the patient s finger No signal No signal from oximeter for more than 300 secs adjustable No signal Oximeter power failure Restart device if alarm persist O2matic PRO 100 needs servic...

Страница 57: ...ist device needs service Battery symbol alarm constant Low battery If device has been without external power recharge the battery Else have the battery changed Check status Battery symbol alarm blinking Critically low battery If device has been without external power recharge the battery Else have the battery changed It is not recommended to use device in this alarm state Power symbol alarm blinki...

Страница 58: ...Further identification can be made in the Device Status screen in the admin menu 5 4 Alarm priorities All pulse oximeter sensor related alarms share the same zone in the following prioritized showing order Devic e Sensor error Oximeter sensor Device needs service Check status Acoustic alarm Restart device if alarm persist Device needs service Check status Back up circuit Check status Memory full D...

Страница 59: ...oup Phenomenon Test method Class Group Conducted RF emissions EN 55011 Class A Group 1 Radiated RF emissions EN 55011 Class A Group 1 Harmonic current emissions EN 61000 3 2 Class A Voltage changes voltage fluctuations and flicker emissions EN 61000 3 3 6 2 Immunity test levels Phenomenon Test method Immunity test level Electrostatic discharge immunity EN 61000 4 2 8 kV contact 2 4 8 kV air Radiat...

Страница 60: ... cycle square wave 780 MHz 9 V m 217 Hz PM 50 duty cycle square wave 810 MHz 28 V m 18 Hz PM 50 duty cycle square wave 870 MHz 28 V m 18 Hz PM 50 duty cycle square wave 930 MHz 28 V m 18 Hz PM 50 duty cycle square wave 1720 MHz 28 V m 217 Hz PM 50 duty cycle square wave 1845 MHz 28 V m 217 Hz PM 50 duty cycle square wave 1970 MHz 28 V m 217 Hz PM 50 duty cycle square wave 2450 MHz 28 V m 217 Hz PM...

Страница 61: ...is a Class II device Immunity to conducted disturbances induced by RF fields AC power ports EN 61000 4 6 3 V 6 V in ISM bands 0 15 80 MHz 80 AM 1 kHz Power frequency magnetic field immunity EN 61000 4 8 30 A m 50 Hz Voltage dips short interruptions and voltage variations immunity EN 61000 4 11 0 UT 0 5 cycle at 0 90 135 180 225 270 and 315 0 UT 1 cycle at 0 70 UT 10 cycles at 0 0 UT 250 cycles at ...

Страница 62: ...ng O2matic PRO 100 should be cleaned after each use Warning Do not clean device while connected to a patient Disconnect the AC power adaptor from the device before cleaning Do not clean device in any other manner than described in this user manual Use wet towel disinfecting wipes or cloth with either water or alcohol Dry off surfaces with a dry towel or cloth afterwards Important Make sure that th...

Страница 63: ...ogs can be used to analyse data more thoroughly For more information see www o2matic com To export data 1 Remove the screws of the USB hatch 2 Make sure that the device is turned on 3 Connect your device to a computer laptop via a standard USB cable 4 Enter the USB password on the device to unlock the USB port 5 Check device connections on your computer It should be showing up like any other USB d...

Страница 64: ...n the top 4 rows is shown the parameters for test setup The next rows show the actual test data provided with one record per second rows It only records during the test Duration time and not the Warmup nor the Recovery time To create your own test Go to the root of the drive and find the file named TESTS Go to the next row row 5 and provide it with a Name Duration Warmup Cooldown Recovery and a va...

Страница 65: ...t in the Settings file see appendix B 7 3 Changing battery The O2matic PRO 100 must use specific rechargeable batteries To ensure safety the battery must be changed by authorized personnel Warning Only use rechargeable and approved Battery Warning Only Authorized Personnel allowed to change battery ...

Страница 66: ...he provided notification shall occur within the applicable warranty period This warranty excludes cost of delivery to and from O2matic ApS O2matic ApS reserves the right to charge a fee for a warranty repair request on any O2matic PRO 100 found to be within specifications O2matic PRO 100 must be repaired by authorized personnel only Any sign or evidence of opening the O2matic PRO 100 other than th...

Страница 67: ...Manual IFU 67 8 4 Support and Contact For support or more information please contact us Website www o2matic com Manufacturer and Technical Support O2matic ApS Nørrelundvej 10 2730 Herlev Denmark 45 5052 9810 Local distributor ...

Страница 68: ...tection Class ll and internally powered Degree of protection Type BF Applied part Ingress protection IPX0 Method of sterilization None Suitability of use Oxygen rich environment Mode of operation Continuous Environmental Operating temperature 5 C 35 C Storage temperature 20 C 60 C Operating humidity 10 90 Storage humidity 10 90 Operating altitude 0 2000 meters Input pressure up to 100 PSI 6 bar Pe...

Страница 69: ... Manual mode 0 20 l min Oximeter Signal Alarm delay 0 300 secs Table A2 Alarm specifications Alarm Specification Type Specification Alarm signal generation delay Less than 2 secs Display update 30 ms Decibel dB 56 Danger SpO2 alarm 3 under low Critical SpO2 alarm Less than 80 Table A3 Default settings table Defaul Type Default Value Pause screen timer 30 mins Mute button timer 120 secs Oximeter Si...

Страница 70: ...x SpO2 Min O2 Flow Max O2 Flow Initial O2 Flow Max Pulse rate Flow response COVID_LFLOW 92 96 0 8 2 130 SLOW COVID_HFLOW 92 96 0 15 5 130 NORMAL COPD_NORM 88 92 0 6 2 130 SLOW ASTHM_PNEUM 94 98 0 10 3 130 SLOW WALKING 90 94 0 15 2 150 FAST Flow response Rate Slow 25 Normal 100 Fast 150 ...

Страница 71: ...omeTimer Time before return to home from inactivity Between 60 and 300 secs SampleDuration Seconds between each session log Between 1 and 30 secs NoSignalAlarmDelay Seconds before a no signal alarm Between 0 and 300 secs LowIntensityAlarmDelay Seconds before low intensity alarm Between 0 and 300 secs TimeSpentUnder AcceptableSpO2 Seconds before long period low intensity alarm Between 60 and 300 se...

Страница 72: ...O2matic PRO 100 Refer to their instructions for use for further information Use only Nonin Purelight pulse oximetry sensors Caution The accuracy of the SpO2 measurement may be affected if the total sensor length including extension cables is greater than 3 meters 6000CA Cloth adult box 6000CI Cloth infant box 6000CN Cloth neonatal box 6000CP Cloth pediatric box 7000A Flexi Form III adult disposabl...

Страница 73: ...or large 8000SM Soft sensor medium 8000SS Soft sensor small 8001J Neonatal flex sensor w 25 FlexiWrap 8001JFW Neonatal FlexiWrap sensor w 25 FlexiWrap 8008J Infant flex sensor w 25 FlexiWrap 8008JFW Infant FlexiWrap sensor w 25 FlexiWrap Masks and catheters O2matic PRO 100 can be used in combination with any standard oxygen mask or nasal catheter Masks and catheters are applied parts for the O2mat...

Страница 74: ...D 8 4 1 20 O2matic User Manual IFU 74 Notes ...

Страница 75: ...D 8 4 1 20 O2matic User Manual IFU 75 Notes ...

Страница 76: ...D 8 4 1 20 O2matic User Manual IFU 76 Notes ...

Страница 77: ...77 O2matic ApS Nørrelundvej 10 2730 Herlev Contact Mail Info o2matic com Web www o2matic com Tel 45 5052 9810 This user manual booklet is current as of January 2022 For information of device updates and news please visit www o2matic com ...

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