Vincent Medical Manufacturing inspired O2FLO, User Manual

Page 1: ...o Ltd User Manual Vincent Medical Manufacturing Co Ltd Flat RM B2 7 F Hang Fung Industrial Building Phase 2 2G Hok Yuen Street Hung Hom Kowloon Hong Kong Tel 852 2365 5688 Fax 852 2765 8428 852 2365 5688 info inspired medical com 852 2186 1010 service inspired medical com ...

Page 2: ...e in this manual to ensure the device is used properly and in a safe manner Please keep this manual for future reference This manual and its corresponding intellectual property rights belong to Vincent Medical Manufacturing Co Ltd Without written consent any individu al or organization must not copy modify or translate any part of this manual P N 10022560 Rev E Release Date 2020 12 03 ...

Page 3: ...r Use 30 3 7 Data Record Software 31 4 Product Maintenance 35 4 1 Filter Replacement 35 4 2 Main Unit Cleaning 36 4 3 Temperature Probe Cleaning and Disinfection 36 4 4 Troubleshooting 37 4 5 Maintenance Statement 38 4 6 Battery Information 38 4 7 Main Unit Leakage Test 39 5 EMC Information 40 5 1 Declaration Electromagnetic Emissions 40 5 2 Guidance Declaration Electromagnetic Immunity 41 6 Use a...

Page 4: ...ot tilted at an angle greater than 10 from the horizontal plane Failure to do so may cause the device to overbalance and or may lead to water spilling out from the chamber This device must be installed with an air inlet filter during use The air inlet filter should be replaced at least once a month in single patient use and after every patient Only approved filters supplied by Vincent Medical shou...

Page 5: ...tric shock or serious device malfunction Do not excessively stretch bend or apply excessive force to cables and hoses NOTE The device should be maintained and serviced only by qualified or trained personnel 4 3 The operator or responsible department should contact Vincent Medical or a Vincent Medical representative for assistance if needed in setting up using or maintaining the device or to report...

Page 6: ...28 C Relative humidity 15 93 RH non condensing Atmospheric pressure 86 106kPa Altitude up to 2000m above sea level Storage and transportation conditions 20 C 50 C 15 93 RH non condensing 86 106kPa Environmental Protection At the end of service life the device and its accessories should be disposed of and decom missioned in accordance with local laws and regulations Contact the appropriate local au...

Page 7: ...s mixture delivered The user can control the oxygen concentration by adjusting the external oxygen valve The upper and lower limits of oxygen concentration alarm is settable to ensure patient safety c Flow Rate Control This device allows the operator to set the flow rate from 2LPM to 60LPM The device monitors the flow rate with a built in highly sensitive flow rate sensor d Mode Control The device...

Page 8: ...ation c Yellow flashing Medium Priority Alarm d Red flashing High Priority Alarm 2 8 inch LCD display Automatically enters the screen saver mode if there is no operation for 10 min Detect water level and presence of chamber to provide water level alarm and chamber uninstalled alarm To detect the chamber outlet temperature patient end temperature and ambient temperature when used 510 090 510 091 He...

Page 9: ...nula Infant VINC 01 S VINC 02 M VINC 03 L VINC 04 XL HU 7 days Yes 510 049 Adult Integrated Heated Breathing Circuit 510 050PaediatricIntegratedHeatedBreathingCircuit VUN 300 Connection Cable Used for 510 049 and 510 050 Remark Home Care HC Hospital Use HU HC HU HC HU HC HU HC HU 14 days 14 days 14 days 14 days Yes Yes Yes Yes Drawing Product Name P N HC HU Maximum Period of Use Single Use 5100789...

Page 10: ...on is detected Select to run in Adult Mode Adult breathing circuit and adult high flow nasal cannula must be used in Adult Mode Select to run in Paediatric Mode Paediatric breathing circuit and paediatric high flow nasal cannula must be used in Paediatric Mode Display oxygen concentration and select to set oxygen concentration alarm limits Select to set Dew Point Temperature at patient end When th...

Page 11: ...late Once the chamber is in the correct position the chamber lock will click into place with the chamber inlet connecting directly into the annular tube of the machine 2 Connect water bag Push the spike at the end of water supply tube into the port at the bottom of the bag Open the vent cap on the side of the spike Hang the water bag above the unit The chamber will be automatically filled to the r...

Page 12: ...3 L 31 34 31 34 31 34 31 34 2 8 2 8 2 10 2 10 31 37 31 37 31 37 10 50 10 60 10 60 Nasal Cannula Adult Model Dew Point Temperature C Flow Rate L min In low ambient temperature conditions the dew point temperature may not reach 37 C when the flow is high User is advised to reduce the target flow setting to achieve the desired dew point temperature Warning The patient interfaces are all single use pr...

Page 13: ...ress the control knob The icon will appear as yellow Rotate the control knob to select Paediatric Mode then press the control knob to confirm The icon will then appear as green If the control knob is not pressed within 10 seconds to confirm the change the system will return to its previous settings Step 3 Use the control knob in a similar manner to set the Dew Point Temperature 31 37 C the target ...

Page 14: ...cian or trained medical professional Oxygen supply shall be standard dry and clean compressed oxygen for medical applications Shut off the oxygen supply before turning off the device Before turning on the oxygen supply run the device to ensure target flow rate can be reached Only turn on the oxygen supply when the device is running Oxygen leakage may cause serious accidents If an oxygen leak is di...

Page 15: ...ace Warning Note that oxygen concentration above 95 will be displayed as 100 In this situation the oxygen reading will flash in red and the device will alarm Warning Note that oxygen concentration below and equal 25 will be displayed as 21 29 31 21 95 18 L Run time 00 00 00 10 D H M S 9 Adjusting settings during operation When the unit is running Dew Point Temperature Flow Rate Oxygen Concentratio...

Page 16: ...up to 100 most recent alarm records can be retrieved 3 5 Alarms The inspired O2FLO is equipped with alarm indicator light auditory alarm signal and on screen information signal to warn about interruptions to patient treatment When an alarm is triggered the status LED flashes in red or yellow and an audible alarm will sound Information describing the alarm will appear on the LCD Warning This alarm ...

Page 17: ...ent medical or yourVincent medical supplier Using wrong chamber or the chamber is not installed properly Thechamberwater levelislowerthanthe centerofprism E1Oxygen concentra tiontransducerfailure E2Flowsensorfailure E4Heaterplatetemp sensorfailure E5Coolingfanfailure E6Turbinefanfailure E8Heaterplateopen circuit E9Memoryfailure Yes 8 15s Medium Adult Mode selected when peadiatric integrated heated...

Page 18: ...n for 2 seconds to shutdown Disconnect the power plug from the mains power If the unit is unplugged when it is running the power out auditory indication will be activated and will sound for more than 120 seconds If the power cord is plugged back into the power supply within 2 minutes the unit will resume running normally Ensure oxygen is not flowing FiO2 54 Insert the SD card properly While in oper...

Page 19: ...ort Data then a folder select dialog will pop up Find the SD Card data folder VM_VUN After importing data the time setting function will be activated The longest time span is 60 days Basic Info 3 7 Data Record Software After finishing editing Patient Info entered will be shown Set Time Setting Patient Info Name N A N A N A N A Age Gender Phone No Start Date Equipment Info Time Period Model No VUN ...

Page 20: ...16 01 16 01 16 01 16 01 16 01 00 02 00 03 00 04 00 05 00 Dewpoint Temperature 00 00 80 64 48 32 16 0 01 16 01 16 01 16 01 16 01 16 01 16 01 00 02 00 03 00 04 00 05 00 Alarm Information and work information Note A warning will be displayed on the LCD screen when the log becomes full This will generate a report with a file name like patient name_phone No pdf Set Start Setting Patient Info Name N A N...

Page 21: ...ater d Dry the filter cover and filter enclosure with a clean dry cloth e Replace the old filter with a new filter f Rotate clockwise to close the filter cover Before installing the filter ensure that the filter is in good condition without defects Clean main unit heater connection cable and VUN 300 connection cable with 75 ethanol solvent to wipe the surface of equipment Warning Do not immerse th...

Page 22: ...parts repair Installers and operators must follow the instructions of installation operation inspec tion and maintenance They must be authorized by Vincent Medical Inspections and maintenance must be performed in accordance with the recommend ed schedule In any of the following circumstances Vincent Medical will not be respon sible for the safety and reliability of the device performance Modifying...

Page 23: ...ld assure that it is used in such an environment RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 The modelVUN 001 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The model VUN 001 is suitable for used in domestic establishment...

Page 24: ... the electromagnetic environment specified below The customer or the user of the model VUN 001 should assure that it is used in such an environment Conducted RF lEC 61000 4 6 Radiated RF lEC 61000 4 3 3Vrms 150 kHz to 80 MHz 6Vrms in ISM and amateur radio bands 10V m 80 MHz to 2 7 GHz 385MHz 5785MHzTest specifications for ENCLOSURE PORT IMMUNI TY to RF wireless communica tion equipment Refer to ta...

Page 25: ...etween Portable and Mobile RF Communications Equipment and the Model VUN 001 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Model VUN 001 150kHz to 80MHz d 1 2 P 80MHz to 800MHz d 1 2 P 800MHz to 2 5GHz d 2 3 P The model VUN 001 is intended for use in an electromagnetic environment in which radiated RF disturbances is controlled The customer or the...