Bedfont NOxBOX mobile Technical Manual Download Page 16

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3.3.4 Rear Label Symbols

Lists name and contact details of device manufacturer.

Year of manufacture: date shown below this symbol indicates the year the

device was made.
Device serial number.

Consult the Instructions for Use.
Caution: specific warnings or precautions for use of this device are listed in

accompanying documents.

Equipment is governed by the WEEE directive. Contact your distributor for correct

disposal of this device.

CE Marked device. Symbol certifies that the product meets EU consumer safety,

health and environmental requirements for this product type.

3.3.5 Front Label Symbols

Intelligent delivery: the system is in fully adaptive delivery mode that controls the

NO dose delivery to the patient to the most efficient and safe delivery profile.

Manual override continuous flow: for emergency backup and manual bagging of

patients. The NO flow is one of the selected flows set by the user. This flow is

continuous and cannot adapt to changing conditions. Patient monitoring must be

observed by operator to ensure correct dose levels are achieved.

3.3.6 Power Supply Symbols

Dangerous Voltage.

Indoor Use Only.

Class II Equipment.

Summary of Contents for NOxBOX mobile

Page 1: ...Technical Guide Issue 5 0 July 2015 saving lives one breath at a time NOxBOXi www bedfont com Software V 17 0 ...

Page 2: ......

Page 3: ... Sector Valve Markings 3 4 System Components 3 4 1 NOxBOXi System Features 3 5 NOxBOXi Effect on Ventilator Circuit 3 5 1 Oxygen Dilution 3 5 2 Measured Minute Volume 3 5 3 Trigger Sensitivity 3 5 4 Maximum NO Dose Delivery 4 Installation 4 1 Unpacking Instructions 4 2 Assemble Delivery Unit to Trolley 4 3 Setup Instructions 4 4 Connecting NO Gas Cylinders 4 5 System Test Setup 5 Patient Circuit S...

Page 4: ... Calibration Access the Calculator Access to Service Engineer Area 6 12 Manual Override 6 12 1 Determine Correct Flow Settings 6 12 2 Using the Printed Look up Tables 6 12 3 Engage Manual Override 6 12 4 Manual Override Flow Selector Approximate NO flow values 6 13 Shutdown 7 Maintenance and Repair 7 1 Periodic Maintenance 7 2 System Settings 7 3 Cleaning the NOxBOXi System 7 4 Calibration 7 5 Sys...

Page 5: ...upport department of Bedfont Scientific Ltd This device has been designed and constructed with high quality components to ensure accuracy reliability and compatibility if third party components are installed without prior consent from Bedfont Bedfont will not be liable for any incident which may occur as a result of this This may also invalidate your warranty The product user bears sole responsibi...

Page 6: ...detected evacuate the affected area immediately Do not re enter the area until safe conditions are restored Ventilate working areas Prevent any leaking gases from accumulating Vent all gases to the outside to an area that is safely away from people Before restarting the equipment ensure that all parts affected by repairs have been restored to their proper operating condition and that the lines hav...

Page 7: ...uipment Determine which hazards you may encounter and be prepared to handle them Refer to the MSDS supplied with the gases and all government egulations and industry safety standards e g COSHH in UK DANGER Exposure to gases or vapours may cause asphyxiation Proceed with caution and in accordance with the MSDS Practically all gases can act as simple asphyxiates by displacing the natural oxygen in t...

Page 8: ...onnel injury or death through breathing absorption through the skin or swallowing Provide adequate ventilation appropriate personal protective equipment PPE and gas detection equipment Adhere to the following guidelines to help guard against possible electrocution This equipment contains toxic gases Adequate ventilation of enclosed areas serves as the chief precaution against an accumulation of to...

Page 9: ...d Labels On locations of the NOxBOXi system where hazards may occur labels such as the one shown in Figure 2 1 4 1 Example Hazard Label No Pushing warn you of any potential dangers Read these labels carefully and be prepared to handle any hazardous situations that may arise If the labels become worn or difficult to read contact your Bedfont representative for replacement labels Figure 2 1 4 1 Exam...

Page 10: ... IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line 2 kV line to earth Mains power quality should be that of a typical hospital environment Voltage dips short interruptions and voltage variations on power supply IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds Met or exceeded Mains powe...

Page 11: ...e predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the NOxBOXi is used exceeds the applicable RF compliance level above the NOxBOXi should be observed to verify normal operation If abnormal performance is observed additional measure...

Page 12: ...e The scope of patient treatment is defined and controlled by the NO drug labelling Primary intended clinical setting is the Intensive Care Unit ICU with a secondary intended clinical setting for the transport of ICU patients 3 1 Intended Use Always handle and store nitric oxide mixtures in accordance with federal national state provincial and local codes and regulations WARNING In the event of an...

Page 13: ... Delivery measured dose At the point of sampling at the patient Y piece the accuracy is that of the monitoring system above Delivery with respect to set point The system will serve the delivered concentration to the set point subject to the flow from the ventilator see section Maximum NO Dose Delivery below for the set point range Once the measured dose and set point agree then the accuracy w r t ...

Page 14: ...ar O2 Battery 4 hours operation Li ion Polymer 745396 3900mAh 22 2V Not User replaceable Power Input EXM 80 5121 100 240 VAC 50 60 Hz 1 7 A Dimensions 330 mm x 250 mm x 108 mm Weight 6 2 kg Construction Rigid polyurethane PU WARNING For high concentrations of NO exceeding 80ppm exposure should be limited to a maximum of 4 days in order to reduce the risk of sensor zero drift due to prolonged expos...

Page 15: ... to return to the previous screen Skip step by step quick start guide instruction screens and skip to Dose Press to accept or confirm the statement on screen Press to decline or deny the statement on screen Greyed out buttons indicate that they are temporarily disabled An action or test must be performed or completed to activate Edit value Main Monitor Alarm mute active when gas alarm is triggered...

Page 16: ...hat the product meets EU consumer safety health and environmental requirements for this product type 3 3 5 Front Label Symbols Intelligent delivery the system is in fully adaptive delivery mode that controls the NO dose delivery to the patient to the most efficient and safe delivery profile Manual override continuous flow for emergency backup and manual bagging of patients The NO flow is one of th...

Page 17: ...or indication of dose per ventilator flow rate Monitoring of patient dose must be implemented when using Manual Override flow delivery of NO 3 4 System Components Each NOxBOXi system has a unique serial unit identification number of the format NI10001 This is found on the device label Figure 0 1 attached to the rear of the device and should be quoted when contacting the manufacturer or distributor...

Page 18: ...ve 4 NOxFlow Sensor Connector 5 NOxFlow Dose Connector 6 Patient Sample Inlet 7 Water Trap Bottle 1 2 3 8 Handle 9 Quick Release Button 10 Power Inlet Socket 11 Charging Indicator LED 12 Zero Inlet 13 USB Port 14 Power Button 15 NOxBOXi gas inlets 4 bar max 16 Gas Line Purge Needle 4 5 6 7 8 9 10 11 12 13 14 15 16 ...

Page 19: ...9 Figure 3 4 1 1 System Features 17 NOxBOXi Nitric Oxide Regulator x2 Connector type dependent on supplier 18 NOxBOXi Supply Lines x2 19 NOxBOXi Power Supply x1 4 International AC plug adaptors included ...

Page 20: ... delivered to the patient to assist the user in monitoring this effect Oxygen dilution is directly related to the proportion of NO gas that is added to the circuit Worked example For a 20 ppm dose from a 400 ppm cylinder 5 NO N2 gas is added to the ventilator air flow the O2 is therefore diluted by 5 of its original value If the O2 was originally 50 v v the O2 concentration after the NO is introdu...

Page 21: ...e NOxBOXi is physically limited This will cause some dose limitations at higher ventilator flow rates The NOxBOXi is compatible with a wide range of NO supply concentrations note that the physical flow limitation has less effect on the 1000 ppm cylinder supply compared to the 400 ppm supply See Figure 3 5 4 1 Graph of NOxBOXi Maximum Dosing Capability NOxBOXi Max Dosing Capability See Figure 3 5 4...

Page 22: ...tallation and for obtaining all necessary approvals 4 1 Unpacking Instructions On first receiving this system the NOxBOXi system should be carefully removed from its packaging and visually inspected Ensure all system components are present and free from visible defect wear or damage Connect device to mains power immediately 4 2 Assemble Delivery Unit to Trolley WARNING When attaching or detaching ...

Page 23: ...ith trolley locking plate and guide monitor down until button locks in position Correctly assembled to locking plate To release head from trolley press quick release button and carefully lift monitor free from the locking plate ...

Page 24: ...Secure each cylinder to the trolley using the straps provided The maximum NO cylinder that the trolley can accommodate is 25 litres water capacity max height 1 2 m Additional space has been provided on the trolley for a small oxygen cylinder if desired 5 Select the number of available NOxBOXi NO supply cylinders that are being setup on the system one or two 6 Ensure that the system is set to intel...

Page 25: ...ing able to correctly alert the medical user to an alarm condition during use 11 The alarm strip and alarm sounder should automatically switch off once the system enters the zero screen If this does not happen then there is a system fault do not use the system 12 Sensor Zero Test The system performs an automatic sensor zero test to establish a baseline reading for the sensors 13 Once complete the ...

Page 26: ...tructions for using the touch screen interface 2 Check that the NOxBOXi NO cylinder concentration matches the value shown on the system screen This is the value upon which delivery calculations will be based Do not use any supply cylinder that does not match this value If there is a problem contact your Service Engineer to resolve before attempting to deliver NO to a patient 3 Check the regulator ...

Page 27: ...indicates line is pressurized If cylinder valve is open the NO gas will escape at high velocity and volume which may quickly create a poisonous atmosphere 4 Attach the regulator to the cylinder valve connection as shown Tighten the connection using the hand wheel Do not use a tool to tighten the regulator 5 If the supply line is not already connected to the regulator then click the quick connector...

Page 28: ...ck introduce to port Push onto port collar springs forward and locks in place When needle is in green area cylinder is full Needle must point to at least 20 bar above red area Check that each supply cylinder has sufficient contents to commence treatment open cylinder valve fully then close valve fully A supply cylinder should have a fill pressure greater than 20 bar before commencing treatment If ...

Page 29: ...e regulator seal and hose connections and look for bubbling in the fluid b Purge the hose line pressure before removing and reattaching the regulator to the cylinder The pressure gauge should always read 0 bar before disconnecting the regulator from the cylinder c Rule out leak in the external regulator and supply line Ensure the regulator supply line connector is correctly locked to the regulator...

Page 30: ...eplaced as soon as practical Repeat the steps above for the second supply line If both lines fail after following the above procedure this may indicate an internal leak in the system The system must be inspected and repaired by a qualified service engineer before being used 4 5 System Test Setup 1 Unwrap a new NOxFlow sensor and unroll the lines 2 Identify the single dose line luer connector and a...

Page 31: ...or the green tube is uppermost 6 Connector will click in place when locked To assist insertion the release button located on the underside of the socket may need depressed whilst attaching connector 8 Connect sample line 7 Unwrap the patient filter and attach the new filter to the rear of the water trap by using the quick release connector Then use the fastening luer lock to complete the connectio...

Page 32: ...connector and assemble one of the female luer ports by pushing it firmly home into the side port of the adaptor Screw the male luer lock at the end of the sample line onto the ventilator adaptor 11 The NOxFlow is marked with a flow direction arrow in green This points in the direction of the ventilator air flow towards the patient sampling point ...

Page 33: ...rrectly prior to connecting to a patient It is vital this step is done to check system function and flush out any NO2 build up before connecting to a patient 14 Connect the Test Line Assembly to a regulated oxygen supply Ensure that the valve on each NO supply cylinder is fully open Set the air flow rate to 10 L min and press the Next button on the monitor to initiate the system test 15 A process ...

Page 34: ...monitor Then re attach the supply lines to Port 1 and Port 2 WARNING If the NOxBOXi system is left pressurized for more than 10 minutes while not in use repeat the system test Connect the Line Assembly to the air supply as described in steps 11 17 Press Next The system test will run automatically Ventilator inspiratory limb showing NOxFlow placement before humidifier 19 Connect the NOxBOXi to the ...

Page 35: ...4 NOxFlow sensor lines 5 2 System Test Circuit System Test Circuit 1 O2 flow meter 2 Oxygen tubing 3 22F 4 6mm connector 4 NOxFlow 5 10M 10F 12M 12F 15M 15F or 22M 22F luer port connector 6 1m corrugated tubing 15mm or 22mm 7 15M 15M luer port or 22M 22F luer port connector 8 NOxBOXi sample line ...

Page 36: ...rs 4 Humidifier 5 0 7m 1 3m Corrugated Tubing 15mm or 22mm 6 NOxBOXi Sample Line 7 10M 10F 12M 12F 15M 15F or 22M 22F luer port connector 8 Patient Y piece 9 Expiratory limb 10 NOxBOXi NOTE To improve accuracy it is recommended to have approximately 30cm between the patient Y Piece 8 and the sample line 6 where possible ...

Page 37: ...low delivery line should be disconnected from the NOxBOXi and a manual bag specific line is connected to the NOxBOXi NO outlet port female leur connection during manual bagging In the case of hyper inflating and self inflating circuits an O2 supply is typically required and can be connected to a variable flow O2 source such as a wall outlet with adjustable flow meter or a cylinder with adjustable ...

Page 38: ...5 3 Hyper inflation Sample line Sample line 1 Hyper inflating bag 2 NO delivery line 3 15M 15F connector 4 Oxygen connector 1 Self inflating bag 2 NOxBOXi T Piece adapter 3 15M 15F connector 22M 22F Connector 4 Oxygen connector ...

Page 39: ...39 5 5 4 Neopuff Resucitator ...

Page 40: ...nally it could also cause irreparable damage to the system Devices that radiate high intensity electromagnetic radiation could affect the correct operation of the NOxBOXi system Ensure that continuous monitoring of the system is undertaken when such devices are in operation within close proximity to the patient Do not improvise connections components or devices for the NOxBOXi system Use only appr...

Page 41: ...ions as NO2 is extremely toxic and a severe pulmonary irritant The NO gas is a mixture of NO buffered in nitrogen Stored in high pressure gas cylinders at a nominal fill of 150 200 bar supplier dependent A high pressure regulator is attached to the valve connector of the gas cylinder This regulator is set to a fixed outlet pressure of 4 bar when the cylinder valve is open and a high pressure conte...

Page 42: ...rap to remove condensate and a drying tube to achieve correct humidity before passing across the three gas sensors where the sample is analysed for the three constituent gases of interest NO NO2 and O2 An electronically controlled valve within the sample circuit can be switched to perform an automat ic zero calibration function This allows the monitor to take a baseline reading of clean air to che...

Page 43: ...n that corresponds to the number of supply cylinders that are to be set up Check the gas Supply Concentration and inspect the regulator for visible damage Attach the Regulator and Connect the Supply Line To navigate through these screens follow the instructions and press the next or back buttons ...

Page 44: ...44 Connect the NOxFlow Sensor Connect the Sample Line Assemble the System Test Open and then close the cylinder valve check the gauge reading and then perform Pressure Hold Test ...

Page 45: ...ect set up Experienced users may also skip straight to dose if they believe that the therapy is needed instantly by pressing Skip to Dose The system must be correctly setup prior to skipping to dose The QSG system tests are provided to help with the correct set up ensure functionality Service Engineers Performing routine maintenance can directly access the Service Engineering Screens from the Home...

Page 46: ...t and follow the on screen instructions The home screen will be displayed on successful completion From the home screen the second test is the main System Test This test requires the user to set up a test circuit The system test is assessing the delivery and monitoring functions are operating correctly Additionally this is an important step to ensure that any build up of NO2 in the system head tha...

Page 47: ...47 Once completed successfully the NOxBOXi is ready for attachment to the patient to commence treatment ...

Page 48: ...oint on the NOxFlow for best performance between 0 7 and 1 3m is ideal The system is now ready for dose entry and alarm setting procedures See Section 5 Patient Circuit Setup for detailed guidance 6 6 Dose Entry and Alarm Setting The NOxBOXi system provides a direct input dose control with a resolution of 0 1 ppm across the dose range from 0 6 80 0 ppm The alarm setting for the monitored gases hav...

Page 49: ... continue 4 The system will display a confirmation screen for the dose entered 5 To accept the displayed value press the check mark 6 To change this value press the Edit The system displays a summary of the entered dose and calculated alarm values The system calculates a default alarm value for the NO High Alarm based on the confirmed NO dose entry The system calculates a default alarm setting for...

Page 50: ...check mark to commence delivery of this dose 10 Press the cross to reject this dose and return to the summary table of values for editing 11 The system will display the main monitor screen The system displays the gas concentrations being delivered to the patient 12 During the first thirty seconds of delivery at a new dose level the system will automatically mute the gas level alarms 6 7 Main Scree...

Page 51: ... to the patient is displayed in the NO Dose box Press the edit button to change the delivered dose The NO supply cylinder status shows cylinders connected to the NOxBOXi The supply indicators warn when the cylinders are low Check the pressure gauge on the regulator to confirm The system concentration setting must match the supply cylinders Call the service engineer if this needs adjusting WARNING ...

Page 52: ...2 3 4 6 7 2 Tabbed Navigation When in normal operation the system will show the main monitoring and delivery screen The main screen has tabbed navigation elements to allow the user to check the alarm history status for this treatment The tab navigation also allows the user to adjust some settings preferences such as language or screen brightness From here it is also possible to access the service ...

Page 53: ... direct entry dose keypad Follow the system instructions the same as when setting the initial dose To change the gas alarm settings press the button corresponding to the alarm to edit image shows edit high NO alarm The edit dose screen shows the current alarm value Press the delete arrow to clear this value and input a new value Press next to proceed the system will return to the main screen once ...

Page 54: ...en can be seen If the screen is touched anywhere whilst the screen lock is active the screen unlock message will appear Tap the key followed by the padlock buttons to unlock The system may be set so the screen can only be unlocked with up to 4 digit code In this instance a keypad is displayed Tap in a valid code and press accept to unlock the screen If the screen lock code has been forgotten conta...

Page 55: ...n the event of a monitored gas alarm being triggered the monitored value flashes red and the gas alarm mute button becomes active Press the mute button for a 2 minute mute of the audible alarm element 6 8 1 Setting the Screen Lock Format The screen lock format is set in the Service Engineer area The system default setting is for a standard non coded screen unlock To change the screen lock format l...

Page 56: ...tery Critical alarms are displayed in a single banner message with a basic guide instruction for alarm resolution Press the cross button to mute the alarm for 2 minutes and dismiss the banner message Drain the water trap using a disposable luer lock syringe Attach to the self sealing plug at base of watertrap withdraw plunger Unscrew syringe and dispose of as per local guidelines Check the sample ...

Page 57: ...ay help resolve this alarm The NOxBOXi has detected a critical fault within the intelligent delivery system and can no longer guarantee safe delivery function Engage the Manual Override see Section 6 12 and replace the system as soon as practical Contact the Systems Engineer 6 9 2 Gas Supply Alarms An amber banner warning alarm is triggered when one cylinder is running low whilst there is a good s...

Page 58: ...y switch to the full cylinder when the current supply cylinder runs too low 6 9 3 Calibration Overdue Zero Calibration During operation the system requires a zero calibration once every 24 hours The first zero is performed during set up as part of the system tests An amber reminder message flags up after 24 hours use to prompt the user to perform the zero test The test takes approximately 2 minute...

Page 59: ...nostics The system performs self tests at set up and during operation to ensure safe performance is maintained In the event that a critical test fails the system will display a full screen notice indicating that the system can no longer be used safely Engage the manual override mode and replace the system as soon as practically possible Alert the Systems Engineer ...

Page 60: ... the system will display this warning to alert the user to the dose setting selected Stop Treatment Set To stop administering Inhaled NO Therapy set the NOxBOXi dose level to zero The system will display warning messages so the user is aware that the stop delivery of treatment mode has been selected Prior to stopping the treatment the system will display this warning to alert the user 6 10 Zero Ca...

Page 61: ... calibration from the main screen 1 Select the Settings tab press Sensor Zero The zero test will take approximately 2 minutes to run A progress animation is displayed under the test table 6 If all sensors perform within the expected parameters a Zeroing Successful message is displayed with green check marks against each sensor result 5 2 When entering the zero calibration screens from either the a...

Page 62: ...tructions 10 If the zero calibration fails the system will prompt to contact the service engineer and replace the system as soon as possible The system will still return to its normal monitoring display and can be used to deliver NO but caution must be used when operating the system with an active sensor fault 6 11 User Settings Screen Changing Display Language On the User Settings Screen change t...

Page 63: ...monitor each time this is due once every 24 hours from system start up The notice can be dismissed if the timing is not suitable e g patient dose recently changed and still adjusting Access the Calculator The Manual Override Calculator refer to section 6 12 1 provides guidance to select a simple delivery bypass setting from 50 600ml to best match the patient requirements Access to Service Engineer...

Page 64: ...e At commencement of NO delivery to the patient it is advisable to check which flow setting on the manual override system would best suit the current treatment session and set flow selector valve to this value 6 12 1 Determine Correct Flow Setting 1 Access the Manual Override Calculator from the user settings screen 2 Use the arrow keys to adjust the ventilator minute flow to match the patient ven...

Page 65: ...e volume flow that most closely matches the patient ventilator settings Each flow setting from 50 600 ml displays the approximate expected NO dose delivery for this minute volume flow based on a 1M length of tubing between theNOxFLOW and the sample line connection Turn the flow valve to the setting most closely matched to the desired patient dose 6 12 3 Engage Manual Override Ensure the Manual Ove...

Page 66: ...w Selector Approximate NO flow values 50 50 cc min 100 100 cc min 200 200 cc min 300 300 cc min 400 400 cc min 500 500 cc min Note all values shown are approximate to 15 Refer to look up tables for indication of dose per ventilator flow rate Monitoring of patient dose must be implemented when using Manual Override flow delivery of NO 6 13 Shutdown When ready to shutdown the system press and hold t...

Page 67: ...e Remove regulator from each cylinder and stow on system trolley Remove all single patient use devices from monitor and dispose of according to local regulations Drain water trap and dispose of drainage syringe Recommend cleaning inside water trap with instrument wipes prior to storage ...

Page 68: ...ed limits CAUTION Check all safety devices at least annually or as otherwise required by local codes or manufacturer recommendations Properly maintain safety valves Never bypass safety devices and never operate the equipment outside its specified limits All repairs and component replacements must be undertaken by a suitably qualified Service Engineer Please contact your supplier for service advice...

Page 69: ...ems Replace and report any damaged or missing accessory and connection items Perform a full scale sensor calibration This must be performed by trained personnel Drain water trap and clean with Bedfont approved wipes Clean unit with Bedfont approved wipes Every 30 days Perform a full scale sensor calibration This must be performed by trained personnel Perform a Pump calibration This must be perform...

Page 70: ...etroleum based solvents alcohol or acetone based solvents Do not autoclave or gas sterilize the system Do not use any abrasive cleaning pads or cleansing fluids on the NOxBOXi system and take particular care not to scratch the touchscreen panel To prevent damage to the touchscreen avoid excessive pressure when cleaning the touch screen panel Ensure that the system is completely dry before returnin...

Page 71: ...s Power Supply with locking jack Model EXM 80 5121 Input 100 240V AC Max 1 7A Output 24V DC 1 7A Use only this power supply NOXBOXI MAIN Portable ambient alarms for NO and NO2 NOAlarm NOXAIR NO V NO2 Alarm NOXAIR NO2 V 2 x Regulator refer to NO gas supplier for valve connection designation ...

Page 72: ... Code Description Image NOXFLOW 2 Size 2 single use flow control unit NOXBOXI SAMPLE Sample line for NOxBOXi WT DRAIN Water trap drainage syringe NOXKIT 2 22 Single use delivery and sampling kit include 3 x 22mm male 22mm female 7 6 port connector 1 8m Sample line 1 x Elbow luer lock NOXFLOW 2 Water trap drainage syringe FIL063 Hydrophobic Filter ...

Page 73: ... line NOXKIT 1 10 Single use delivery and sampling kit includes 2 x 10mm male 10mm male 7 6 port connector 1 x 10mm male 10mm female 1 x Elbow luer lock NOXFLOW 2 Water trap drainage syringe 1 8m Sample line NOXKIT 2 12 Single use kit for adapting 10mm kit to 12mm circuits NOXBOX I TEST System test kit Includes 1 200mm corrigated tubing sample line oxygen line 22f 6mm oxygen line connector NOXFLOW...

Page 74: ... has been repaired other than by Bedfont an authorised Bedfont representative trained in repairs or in accordance with those individuals trained by Bedfont in repairs or altered by anyone other than Bedfont or if the product has been subject to abuse misuse negligence or accident Prepaid means packing carriage taxes import duties and any other costs incurred in sending the product back for repair ...

Page 75: ...t very low trickle charge to maintain its calibration In the event that the system is not stored on mains power charge after an extended period of time the battery may completely discharge and the sensors will lose their calibration bias In the event of power loss connect the unit to mains power and allow 6 hours for the unit to charge before calibrating the NO sensor and re comissioning the unit ...

Page 76: ...lator settings deem necessary The NO sensor may require replacing If another system is not readily available and patient requires therapy engage the manual override mode replace the system as soon as practically possible and alert the Service Engineer NO High Monitored levels of NO gas being delivered to the patient have risen above the alarm setting boundary NOxBOXi delivery system cannot maintai...

Page 77: ...trap including barrel thread for damage and or leaks Check sample line is correctly attached to ventilator circuit and NOxBOXi water trap inlet Check no ventilator circuit breaks or leakages have occurred The NO gas is balanced in N2 this is an asphyxiant gas At high NO dose levels for low concentration cylinders e g 200 ppm the level of gas delivered into the ventilator stream can reduce the v v ...

Page 78: ...ct power supply and reconnect check blue charging L E D is lit indicating mains supply OK If not try a different mains power supply If possible replace NOxBOXi power supply and alert service engineer In the event that no mains power can be restored to the device be prepared to engage the manual override mode Cylinder Supply Critical NOxBOXi detects that available NO gas supply is running low and n...

Page 79: ...bration is fully automatic Press the tick to start the zero calibration The zero calibration can be delayed if the system is not currently in a stable dose delivery state e g If the patient dose has recently been changed and the system is still stabilising to the new dose level dismiss this alarm message and perform the zero when the notice next appears Zero Calibration Fail One or all of the sens...

Page 80: ...nother system is not readily available and patient requires therapy engage the manual override mode replace the system as soon as practically possible and alert the Service Engineer Zero Calibration Fail One or all of the sensors have failed the zero low calibration Ambient conditions may be affecting the zero sample Check ambient NOxAIR monitor for high levels of NO If high levels are detected ch...

Page 81: ...Fail The NOxBOXi has failed the safety test and cannot accurately deliver and monitor Nitric Oxide in intelligent mode Check the Oxygen source is flowing Check the NOxFLOW is connected to the Oxygen source and the NOxBOXi TEST kit Check the correct orientation of NOxFLOW Check the NOxFLOW is connected to the NOxBOXi Check NOxFLOW flow detection lines and connector O rings for damage Check sample l...

Page 82: ...82 Notes ...

Page 83: ...83 Notes ...

Page 84: ...k bedfont com www bedfont com Issue 5 0 July 2015 Part No LAB638 Bedfont Scientific Ltd Bedfont Scientific Limited reserves the right to change or update this literature without prior notice Registered office England and Wales Registered No 1289798 ISO 9001 2008 Cert No FM 31664 ISO 13485 2003 Cert No MD 502905 ...

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