Noxbox®o2 - Noxbox Ltd

Transcript

NOxBOX O2 ® www.noxboxltd.com NOxBOX®O2 Operating Manual English Contents 1 Intended use 3 2 Safety 3 Basic Safety Recommendations 3 3 Safe Operation Notes 3 4 Environment 4 5 Warnings 6 6 Important Notices Single-Use Cleaning Maintenance and Storage Contraindications 6 6 6 7 7 7 Specification 8 Symbols 8 2 8 Instrument layout 9 9 8 Operation 10 Pre-use checks 10 Setting up the NOxBOX®O2 10 Connecting to the Patient Circuit 10-11 Switching Off 12 ® NOxBOX O2 Display 13 10 Alarms Setting Alarms 14 14 11 15 15 16 17 17 Calibration Sensor Zero NO Calibration NO2 Calibration O2 Calibration 12 Troubleshooting Resolving Alarms 18 18-20 13 20 Returns Procedure 14 Spares 21 15 Warranty 21 Intended use The NOxBOX®O2 is intended for use by healthcare professionals for monitoring the levels of nitric oxide (NO), nitrogen dioxide (NO2) and oxygen (O2) delivered to a patient undergoing INO inhaled nitric oxide therapy). Safety Do not operate this equipment until you have read and understood the operating, maintenance and safety instructions included in this manual and any manuals supplied with the INO therapy delivery system being used. Only trained and responsible personnel should work with or around this equipment. To avoid serious injury, pay attention to all precautionary labels attached to equipment, cylinders, containers and boxes prior to start-up. Do not remove or obscure any label. If a label is missing, becomes worn, or is difficult to read, replace it with a new one. Product labels for the NOxBOX®O2 are available from your distributor or NOxBOX Ltd representative. Advice to the responsible organisation that the assembly of medical equipment systems and modifications during the actual service life require evaluation to the requirements of EN60601-1:2006. Basic Safety Recommendations To prevent formation of unsafe atmospheres, ensure that properly engineered ventilation and atmospheric monitoring systems are installed and operating properly. Creating a confined space presents the potential for unsafe atmospheres. If dangerous levels of a gas are detected, evacuate the affected area immediately. Do not re-enter the area until safe conditions are restored. required by local codes or manufacturer recommendations. Never bypass safety devices, and never operate the equipment outside its specified limits. Ensure safe maintenance and repair - Only qualified personnel should repair the equipment. Ensure equipment is maintained according to the manufacturer’s recommendations, including any calibration or inspection routines. Safe Operation Notes To avoid electric shock, this equipment must be connected to a mains supply with a protective earth. The operator should not touch the patient whilst in contact with either the computer or the USB connector parts. The NOxBOX®O2 should only be connected to a computer that is manufactured in accordance with EN60950 Safety of information technology equipment. Ensure the monitor is out of reach of the patient when in operation, at a distance of at least 1.5m Please do not attempt to modify the equipment in any way or use accessories not specified by the manufacturer. Any attempt to do so will invalidate the warranty and may affect the safety of the device. The monitor is not suitable for use in an oxygen rich environment. The monitor uses a sampling tube that may come into contact with the patient’s skin during normal procedures. For this reason, the sample tube is considered as an Applied Part but it is safe to use and offers no risks to the patient or user. To prevent injury, ensure that all tools and instruments used are in good condition. Maintain safety devices - Check all safety devices at least annually or as otherwise www.noxboxltd.com 3 English NOxBOX®O2 Operating Manual NOxBOX®O2 Operating Manual English Environment The NOxBOX®O2 complies with the directive EN60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding the levels specified in EN50082:1 Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2) The NOXBOX®O2 is intended for the use in the electromagnetic environment specified below. The customer or the user of the NOxBOX®O2 should assure that it isused in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) ±6 kV contact ±6 kV contact ± 8 kV air ± 8 kV air Floor should be wood,concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidiity should be at least 30%. Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines IEC 61000-4-4 ±1 kV for input/ output lines Mains power quality should be that of a typical commerical and/or hospital enviroment. Surge ±1 kV line to line ±1 kV line to neutral ±2 kV line to earth ±2 kV line to earth Mains power quality should be that of a typical commercil and/or hospital enviroment IEC 61000-4-2 IEC 61000-4-5 <5 % U (>95 % dip in UT) for 0.5 cycle Voltage dips, short interruptions and voltage variations on power supply IEC 61000-4-11 40 % U (60 % dip in UT ) for 5 cycles 70 % U (30% dip in UT) for 25 cycles <5 % U (95 % dip in UT) for 5 cycles Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8 3 A/m 60 % dip to x 5 cycles Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the NOxBOX®O2 requires continued operation during power mains interruption, it is recommended that the NOxBOX®O2 be powered from an uninterruptible power supply or battery. 100% dip for 5s 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the A.C. mains voltage prior to application of the test level. 4 Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2) The NOxBOX®O2 is intended for the use in the electromagnetic environment specified below. The customer or the user of the NOxBOX®O2 should assure that it is used in such an environment. Immunity test Conducted RF IEC 61000-4-6 IEC 60601 Test level 3 V rms 150 kHz ~ 80MHz outside ISM bands* 10 V rms 150 kHz ~ Radiated RF IEC 61000-4-3 Compliance level 3 V rms 10 V/m 80MHz in ISM Electromagnetic environment– guidance Portable and mobile RF communications equipment should be used no closer to any part of the NOxBOX®O2 including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Interference may occur in the vicinity of equipment marked with he following symbol: bands* 10 V rms 80 kHz ~ 2.5 GHz 80MHz to 2.5GHz Note1: At 80 MHz and 800 MHz, the higher frequency range applies. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be 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 NOxBOX®O2 is used exceeds the applicable RF compliance level above, the NOxBOX®O2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NOxBOX®O2. Over the frequency ranges 150 kHz to 80 MHz field strength should be less than 3 V/m. The NOxBOX®O2 is intended for use in the electromagnetic environment specified below. The user of the NOxBOX®O2. should assure that it is used in such an environment Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Compliance Electromagnetic environment - guidance Group 1 The NOxBOX®O2. 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. Class B The NOxBOX®O2. is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. A separation distance is not applicable to the NOxBOX®O2 since it does not incorporate intentional transmitters. It is however good practice to keep at least 300mm separation from other equipment used in the same environment. www.noxboxltd.com 5 English NOxBOX®O2 Operating Manual NOxBOX®O2 Operating Manual English Warnings Important Notices DANGER: Poisonous gases can be fatal if inhaled, even in very small quantities. Provide adequate ventilation and appropriate personal protective equipment (PPE). Single-Use This equipment monitors poisonous gases. The Threshold Limit Value (TLV) for each gas refers, in general, to airborne concentrations at or below which nearly all workers may be repeatedly exposed without adverse effects. The TLVs for the specialty gases used with this equipment should be stated on the cylinder body labels and the MSDSs (Material Safety Data Sheets) for each gas. The following items listed and approved for use with the NOxBOX®O2 are single-patient use only. These items are not reprocessible and should be properly disposed of after use according to local guidelines for such items: ●● The protective filter ●● The sample line ●● The water trap drainage syringe 1 Nitric Oxide (NO): Cleaning At room temperature and atmospheric pressure, NO is a colourless, odourless, toxic, non-flammable gas. It will readily combine with atmospheric oxygen to form NO2. Wipe the instrument and external surfaces with a product specifically developed for the purpose. NOxBOX Ltd provides Instrument Cleansing Wipes. Nitrogen Dioxide (NO2): ●● Never use alcohol, cleaning agents containing alcohol, or other organic solvents to clean the monitor. Vapours from such chemicals will damage the internal sensors. NO reacts with atmospheric oxygen to produce NO2; the NO2 may react further with water to produce nitric and nitrous acid which can both be extremely corrosive. The human lungs are a wet environment, so inhalation of this extremely toxic gas can have severe effects and every reasonable measure should be made to minimise exposure to NO2. Current UK HSE guidelines recommend following the Chemical Hazard Awareness Notice (CHAN) for nitrogen oxides (including NO and NO2) state that time weighted average (TWA) over eight hours should not exceed 1ppm. Nitrogen (N2): Nitrogen gas is an asphyxiant. A major component of air, it is colourless and odourless at room temperature. Care should be taken to avoid excessive release of Nitrogen into the atmosphere without adequate ventilation to protect the user from a low-oxygen atmosphere being created. 6 ●● Under no circumstances should the instrument be immersed in or splashed with liquid. ●● NOxBOX®O2 is not suitable for sterilization. ●● To clean the water trap, use any of the three fluid path luer lock ports to introduce cleaning fluid. Do not use any alcohol or organic-based solvents to clean the water trap as this may damage the sensors. Do not submerge the water trap in liquids as this may cause damage to the electrical sensor. ●● Ensure all cleaning substances are thoroughly drained and removed from the water trap before use. English NOxBOX®O2 Operating Manual Maintenance and Storage ●● Calibration should be checked regularly, in accordance with the instructions in this manual (see “Calibration” section, Page 13). ●● Temperature may affect the accuracy of the NOxBOX®O2. The instrument should be calibrated at the temperature at which it is expected to be used. If the NOxBOX®O2 is used at a lower temperature than when it was calibrated, readings may be lower; if used at a higher temperature than when calibrated, readings may be higher. NOxBOX Ltd will make available on request circuit diagrams, components part lists, descriptions, calibration instructions, or other information which will assist the user’s appropriately qualified technical personnel to repair those parts of equipment which are designed by the manufacturer as repairable, following service training. Contraindications ●● The nitric oxide sensor is cross-sensitive to nitrogen dioxide, but not significantly enough to affect the unit during use. ●● Refer to your NO drug manufacturer’s instructions for use, safety and warning statements regarding contraindications for the application of nitric oxide gas for the purpose of INO therapy. ●● Prior to storage, ensure that the NOxBOX®O2 is correctly decommissioned following use. See “Operation” section, “Switching Off” Page 10. ●● NO gas is toxic at high concentrations and appropriate continuous monitoring of the applied patient dose concentration should be used. ●● Store the NOxBOX®O2 connected to the mains supply to prevent the battery losing charge. In the event that the battery discharges, the sensors will no longer be biased. ●● WARNING: Sudden cessation of INO therapy can cause complications such as rebound hypoxia to occur. ●● In the event of sensor bias being lost, the unit needs to be plugged in to the mains for at least 6 hours (recommended 24 hours) before performing a full sensor calibration (see Calibration section, Page 13). ●● In the event of a sensor failing to calibrate, or if a sensors performance begins to degrade, the sensor needs to be changed. Refer to the NOxBOX®O2 maintenance manual for instructions on sensor replacement. This can only be performed by a NOxBOX Ltd qualified service engineer or the unit warranty will be void. ●● Typical life expectancy for the NOxBOX®O2 sensors is 1 – 2 years when correctly maintained and operated according to these instructions. www.noxboxltd.com 7 NOxBOX®O2 Operating Manual English Specification Measuring range: 0-99.9 ppm NO 0-19.9 ppm NO2 0-100% O2 Means of disconnection Mains plug Mode of operation: Continuous Sample flow rate: Approx. 250 ml/min Detection principle: Sealed electrochemical sensor Accuracy: <5% of reading Display: Graphical LCD Alarms: Audible and visible Warm-up time: <2 minutes Response time: <10 seconds to 90% FSD NO <30 seconds to 90% FSD NO2 Operating temperature: 10-40°C Operating Humidity: 30-75% Transport/storage temperature: 10-40°C Transport/storage humidity: 30-75% Operating/transport/storage pressure: 700-1013mbar Sensor operating life: 1-2 years Sensor resolution: 0.1ppm NO and NO2 Battery: 4-6 hours (operational) 12v, 2.3Ah (YUA5A;NP2.3-12) Power input: 230v, 50Hz/60Hz, 110mA (optional)115v, 60Hz, 220mA Dimensions: 240 (D) × 210 (W) × 140 (H) mm Weight: Approx. 4 kg (including batteries) Construction: Aluminium Ceramic fuse: T 315mAH 250V (x2) IEC 60127 Compliant Ceramic fuse: T 160mAH 250V (x2) IEC 60127 Compliant Symbols Alternating current Direct Current Degree of protection against electric shock: Type BF applied part Degree of safety of application in the prescence of a flammable anaesthetic mixture with air oxygen or nitrous oxide: Equipment not suitable for use in the presence of flammable mixtures. 8 Type of protection against electric shock: Internally Powered Equipment Class I equipment; (earthed) iNO therapy can be hazardous if not Caution applied correctly. Please refer to the warnings and safety notes in this manual Degree of protection against ingress of liquid: IPXO - not protected against water ingress Consult instructions for use English NOxBOX®O2 Operating Manual Instrument layout 1 NO high alarm control 12 Cut-off valve (Not used) 2 NO low alarm control 13 Exhaust 3 NO2 high alarm control 14 Sample Inlet 4 O2 low alarm control 15 5 Manual zero IEC power socket 230v (115v, optional) 6 NO/NO2/O2 calibration adjusters 16 Anti-surge fuses 7 LCD screen 17 On/off Switch 8 Mute button 18 Water trap 9 Charging LED 19 Luer lock release valve 10 Water trap sensor connector 20 Protective filter 11 Zero reference 21 USB (optional) 22 Handle 1 3 22 21 6 11 12 10 20 5 2 14 4 19 15 16 7 17 ! 13 9 8 18 CAUTION: Ensure that the mains plug is not obstructed to facilitate easy removal from the mains socket. www.noxboxltd.com 9 NOxBOX®O2 Operating Manual English Operation The NOxBOX®O2 is supplied assembled and ready for use. Prior to shipment, all units are zeroed with pure air and calibrated with certified NO in N2 and NO2 in air. 3. Once the auto zeroing process is complete, check that the NO and the NO2 readings are 0.0ppm, and that the O2 reading is 20.9% (±0.2%) absolute. 4. If the unit is out of calibration, it must be calibrated prior to use to ensure reliable reading of the dose. To calibrate the unit, follow the procedure described in Calibration, Page 13. 5. Adjust the four gas alarms (described under Alarms section, Page 12) at levels appropriate to facilitate best monitoring and awareness for the individual patient treatment. 6. The NOxBOX®O2 is now ready to connect to the patient circuit. Pre-use checks ●● Ensure that the water-trap is empty before use. ●● If the water trap needs emptying, use the supplied drainage syringe by screwing onto the water trap Luer lock on the rear of instrument (see Instrument layout, page 7) and drain the water if required. ●● Calibration is recommended once a week during use, or once a month during storage. NOxBOX Ltd recommends that the unit is calibrated prior to use if calibration has not been carried out within these timescales. Follow the instructions for calibration on page 13. ●● Checking the function of this critical care piece of equipment is important and these instructions must be adhered to. Setting up the NOxBOX®O2 Connecting to the Patient Circuit 1. Install a new patient filter to the exit of the water trap. Twist the blue luer collar on the water trap exit to the filter inlet (filter inlet side printed with FIL042A, see Fig. 1). Twist the blue luer collar on the green tubing to the filter outlet (see Fig. 1). NOTE: Filter is a single-patient use item and must be replaced before each use. Connect the power lead to the NOxBOX®O2 via the socket on the rear panel (see Instrument Layout, Page 7). Connect to the electricity supply. The charging LED located at the front of the monitor should now be illuminated. NOTE: on units with serial number up to NBO454, this LED will be located to the rear of the monitor. 1. Switch the monitor on using the on/off switch at the back of the unit. The green LED on the power switch should light up. 2. The NOxBOX®O2 monitor will begin auto zeroing and ‘Zeroing’ will be displayed while this process takes place. Figure 1: Patient Filter correctly installed 10 2. 3. Unwrap a new patient sample line. Attach the female luer end to the blue luer collar on the water trap inlet. The free end of the line will attach to the patient circuit using a luer-port adaptor connector. The NOXKIT-V with NOXKIT- NEONATE, NOXKIT-CHILD or NOXKIT- ADULT, available from NOxBOX Ltd or your distributor, contains standard size vent circuit adaptors with luer ports to allow simple connection to most ventilator circuits. English NOxBOX®O2 Operating Manual 2 The sample point on the patient circuit should be located on the inspiratory limb, as close as possible to the patient Y-piece as possible (Fig. 2). NOxBOX Ltd recommends that a one-way valve is installed between the patient and the sampling point to prevent dilution effects from patient exhalant gas. This will allow for the most accurate reading of the dose. Figure 2: Connection to patient Figure 2-a: Connection Including NOxBOX Mobile www.noxboxltd.com 11 NOxBOX®O2 Operating Manual English Switching Off 1. Once the treatment is complete and the NOxBOX®O2 is no longer required, follow these steps to safely decommission ready for cleaning and storage: 2. Disconnect the patient sample line from the ventilator circuit. Disconnect patient sample line from water trap luer. Dispose of patient sample line in accordance with local procedures for such items. 3. Disconnect the patient filter from the outlet of the water trap and inlet to the monitor. Dispose of patient filter in accordance with local procedures for such items. 4. Drain the water trap using an appropriate clean syringe. Drainage syringes can be obtained from NOxBOX Ltd or your distributor. Dispose of the syringe in accordance with local procedures for such items. 5. Switch off the NOxBOX®O2 monitor using the power switch at the rear. Disconnect the mains plug from the wall socket. 6. Clean the device in accordance with local procedures prior to storage. IMPORTANT: read all safety notices and warnings relating to cleaning products to prevent damaging the monitor. 7. NOxBOX®O2 is ready for storage. NOTE: Read “Maintenance & Storage” section under “Important Notes, Page 5,” at the front of this manual. 12 English NOxBOX®O2 Operating Manual NOxBOX®O2 Display A 0.0PPM NO: B 0.0 NOHi = 30/6 25.0 NO2hi = 2.0 12.0 20.9 O2 NO2 % C PPM NOLo = 00.0 O2low = 16.0 PMP /B H2O BATlow D Figure 3: NOxBOX®O2 display, labelled The sample gas monitored values are displayed in the upper section of the screen in Fig. 3. A. Nitric oxide gas in parts per million (ppm) B. Nitrogen dioxide gas in ppm C. Oxygen gas as percentage (%) The lower section of the screen displays alarm settings and messages D. Seen in Fig. 3. Reading from top left to bottom right: ALARM INDICATION RANGE NOHi Shows value at which the NO high alarm is set (ppm) 0 – 99.9 NOLo Shows value at which the NO low alarm is set (ppm) 0 – 99.9 O2low Shows value at which the O2 low alarm is set (%) 16.0 – 99.9 NO2hi Shows value at which the NO2 high alarm is set (ppm) 0 – 19.9 PMP/B Flashes and sounds when pump or sample line is blocked --- H2O Flashes and sounds when water trap needs to be drained --- BATlow Flashes and sounds when battery is low --- www.noxboxltd.com 13 NOxBOX®O2 Operating Manual English Alarms In the event of an alarm, the display will flash to indicate which alarm has been triggered and an audible alarm tone will sound. The NOxBOX®O2 monitor has a mute button located directly under the display, press and hold for 3 seconds to mute the alarm for approx. 2 minutes. Setting the NO2 high alarm Setting Alarms ●● Adjust “O2 low” control dial until O2 low displayed on the screen reaches the appropriate value and is stable. The four gas level alarms are user set via the control dials located on the right hand side of the monitor (See “instrument layout”, Page 7). ●● Setting the gas level alarms to the correct level is dependent on the healthcare professional, and should be used appropriately. ●● NOxBOX Ltd recommends that the gas level alarms are set to raise an alert in the event that the patient circuit gas levels are reading out of acceptable bounds, based on the conditions set for that patients, e.g. oxygen level and intended NO dose level. ●● When changing any settings within the patient circuit that may affect the monitored levels, remember to make any appropriate adjustments to these alarms. Setting the NO high alarm ●● Adjust “NO hi” control dial until NOHi displayed on the screen reaches the appropriate value and is stable. This should always be set at more than the desired NO dose level. Setting the NO low alarm ●● Adjust “NO low” control dial until NOLo displayed on the screen reaches the appropriate value and is stable. This should always be set at less than the desired NO dose level. 14 ●● Adjust “NO2 hi” control dial until NO2 hi displayed on the screen reaches the appropriate value and is stable. Setting the O2 low alarm ●● NOTE: minimum setting is 16.0% Calibration Calibration of the NOxBOX®O2 should be carried out once a week during use and once a month during storage. Refer to the safety notices on handling toxic and asphyxiating gases at the front of this manual. Refer to the individual gas MSDSs for full safety data for the gas being used. The area used to calibrate the NOxBOX®O2 should be well ventilated and appropriate PPE such as safety goggles should be worn. Use an ambient environmental monitor for NOx gases such as the NOxAIR personal alarms available from NOxBOX Ltd during calibration. Sensor Zero IMPORTANT: Before carrying out any calibration procedure, it is essential for the NOxBOX®O2 to complete a full zeroing process which sets the baseline reading for the sensors. No special gas connections are required. ●● The NOxBOX®O2 will automatically zero as it is switched on, wait until the screen displays the normal monitoring screen before calibrating. ●● If the unit is already on prior to commencing calibration, perform a manual zero by pressing the button located next to the alarm adjustment dials on the right of the monitor. The zero process should take approximately 2 minutes. 1 NOTE: During the zero, the screen will display “zeroing” (Fig. 4) and display two sets of numbers below this. These numbers are for diagnostic purposes should there be a problem with the calibration procedure, and can help the technical support team diagnose any issues that may have occurred with the monitor. ZEROING 10 58 Figure 4: NOxBOX®O2 display, showing Zeroing www.noxboxltd.com 15 English NOxBOX®O2 Operating Manual NOxBOX®O2 Operating Manual English IMPORTANT: Ensure the NOxBOX®O2 unit has been stored correctly on charge prior to calibration. If the unit battery has been allowed to run down, the sensors may lose bias and the unit must be connected to the mains and left on charge for a minimum of 6 hours to ensure the sensor is fully biased prior to calibration. Nitric oxide (NO) Calibration IMPORTANT: Ensure the NOxBOX®O2 readings are at or near expected baseline values (NO = 0.0, NO2 = 0.0, O2 = 20.9%) before performing the NO calibration procedure. If following on from another sensor calibration, this process should take no more than 2 – 3 minutes. Calibration Gas: A certified gas cylinder containing 25ppm NO balanced in nitrogen, supplied by NOxBOX Ltd. ●● Once the NO value displayed is stable, the display reading can be adjusted to match the value of the certified calibration gas. Using the calibration screwdriver supplied, locate the tip of the screwdriver into the “NO span” potentiometer screw located on the right side of the monitor. Gently turn the screw to adjust the displayed value as appropriate. ●● Turn the control valve on the regulator off to stop the flow of NO gas. ●● Disconnect the calibration line from the water trap. ●● Disconnect the regulator from the calibration cylinder. 2 Procedure: ●● Attach the stainless steel miniature regulator, supplied by NOxBOX Ltd to the gas cylinder valve. Ensure the control valve is closed. ●● The outlet of the regulator should be attached to the supplied calibration line clear plastic NOX-Y-CAL tubing. This tubing has a y-piece exhaust to ensure that the sensors receive the correct level of gas and are not damaged by over-pressure. ●● Connect the luer on the free-end of the calibration tubing to the inlet luer of the water trap on the NOxBOX®O2 (See figure 5.) ●● Open the control valve on the regulator. The flow is automatically set to approximately 1 litre per minute (±0.2ltr/ minute). ●● Allow approximately three minutes for the NO gas reading to stabilise. NOTE: during this procedure, the O2 level will fall to near zero, causing the O2low alarm to be triggered. The calibration gas contains no oxygen, this is normal. Mute alarm during NO calibration. 16 Figure 5: Calibration Procedure Nitrogen dioxide (NO2) Calibration ●● Disconnect the calibration line from the water trap. IMPORTANT: Ensure the NOxBOXO2 readings are at or near expected baseline values (NO = 0.0, NO2 = 0.0, O2 = 20.9%) before performing the NO2 calibration procedure. If following on from another sensor calibration, this process should take no more than 2 – 3 minutes. Oxygen (O2) calibration Calibration Gas: A certified gas cylinder containing 10ppm NO2 balanced in air, supplied by NOxBOX Ltd. 3 Procedure: ●● Attach the stainless steel miniature regulator, supplied by NOxBOX Ltd to the gas cylinder valve. Ensure the control valve is closed. ●● The outlet of the regulator should be attached to the supplied calibration line clear plastic NOX-Y-CAL tubing. This tubing has a y-piece exhaust to ensure that the sensors receive the correct level of gas and are not damaged by over-pressure. ●● Connect the luer on the free-end of the calibration tubing to the inlet luer of the water trap on the NOxBOX®O2. ●● Disconnect the regulator from the calibration cylinder IMPORTANT: Ensure the NOxBOX®O2 readings are at or near expected baseline values (NO = 0.0, NO2 = 0.0, O2 = 20.9%) before performing the O2 calibration procedure. If following on from another sensor calibration, this process should take no more than 2 – 3 minutes. Calibration Gas: Scrubbed ambient air at 20.9% Procedure: ●● Allow the NOxBOX®O2 readings to return to the normal baseline values and stabilise. ●● Using the calibration screwdriver supplied, locate the tip of the screwdriver into the “O2 span” potentiometer screw located on the right side of the monitor. Gently turn the screw to adjust the displayed value as appropriate. ●● Open the control valve on the regulator. The flow is automatically set to approximately 1 litre per minute (±0.2ltr/ minute). ●● Allow approximately three minutes for the NO2 gas reading to stabilise. ●● Once the NO2 value displayed is stable, the display reading can be adjusted to match the value of the certified calibration gas. Using the calibration screwdriver supplied, locate the tip of the screwdriver into the “NO2 span” potentiometer screw located on the right side of the monitor. Gently turn the screw to adjust the displayed value as appropriate. ●● Turn the control valve on the regulator off to stop the flow of NO2 gas. www.noxboxltd.com 17 English NOxBOX®O2 Operating Manual NOxBOX®O2 Operating Manual English Troubleshooting Resolving Alarms In the first instance of an alarm sounding, the effect on the patient, their condition and treatment is the overriding priority. Check and safeguard patient condition before attending to the monitor. The following advice should help resolve the alarm condition. If the advice herein fails, contact your service engineer for assistance. It may be appropriate to replace a malfunctioning monitor in worst case. being a fault with this monitor. ●● If all above steps have not resolved the issue, consider replacing the NO supply cylinder. IMPORTANT: the NO gas flow levels should not deviate substantially (e.g. > +/- 30%) from the guideline settings recommended for the patient vent flow and NO supply cylinder. Rule out a fault with the monitoring equipment before substantially altering the NO flow from the delivery device. NOLo For any on-going issues, or to obtain more in-depth technical assistance on these products, please contact NOxBOX Ltd’s technical support at www.noxboxltd.com and click on “Technical support”. ●● Check patient is still breathing. ALARM / ACTION: ●● If O2low alarm is sounding at the same time, there is likely to be a leak in the patient sample path. Check connection of patient sample line connection to the ventilator and NOxBOX®O2 is free from leaks. 1 NOHi ●● Check patient is still breathing. ●● Check inspiratory ventilator flow is present and free from leaks or broken connections. ●● Check NO delivery device flow setting is correct for patient ventilator flow and NO supply cylinder concentration. ●● If appropriate, reduce NO flow from delivery device and allow 2 minutes before re-assessing NO levels. NOTE: the 2 minutes allows the full impact of any changes to be recorded. ●● Perform a manual zero on the NOxBOX®O2 by pressing the zero button on the right side of the monitor. NOTE: this process takes approximately 2 minutes. ●● If NO reading is still high, replace the monitor for another unit to exclude there 18 ●● Check inspiratory ventilator flow is present and free from leaks or broken connections. ●● Check connection of NO supply line from delivery device to ventilator circuit is free from leaks. ●● If PMP/B alarm is sounding at the same time, the low NO reading may be due to a kink or blockage in the sample path. Resolve this alarm and monitor system for 2 minutes to see if the NO level reading recovers. ●● If NO2hi alarm is sounding at same time, the delivery gas system may have suffered oxidisation. This can be resolved by purging the delivery system lines. Refer to the delivery system manual for instructions and warnings on purging. ●● Check NO delivery device flow setting is correct for patient ventilator flow and NO supply cylinder concentration. ●● If appropriate, increase the NO flow from delivery device and allow 2 minutes before re-assessing NO levels. NOTE: the 2 minutes allows the full impact of any changes to be recorded. for 2 minutes to see if the O2 level reading recovers. ●● Perform a manual zero on the NOxBOX®O2 by pressing the zero button on the right side of the monitor. NOTE: this process takes approximately 2 minutes. ●● Perform a manual zero on the NOxBOX®O2 by pressing the zero button on the right side of the monitor. NOTE: this process takes approximately 2 minutes. ●● If NO reading is still high, replace the monitor for another unit to exclude there being a fault with this monitor. ●● If O2 reading is still low, replace the monitor for another unit to exclude there being a fault with this monitor. ●● If all above steps have not resolved the issue, consider replacing the NO supply cylinder. NO2hi IMPORTANT: the NO gas flow levels should not deviate substantially (e.g. > +/- 30%) from the guideline settings recommended for the patient vent flow and NO supply cylinder. Rule out a fault with the monitoring equipment before substantially altering the NO flow from the delivery device. O2low ●● Check patient is still breathing. ●● Check inspiratory ventilator flow is present and free from leaks or broken connections. ●● Check NO delivery device flow setting – at high flow rates, there can be significant volumes of N2 gas being delivered into the patient ventilator lines which can dilute the O2 levels. Adjust relevant equipment settings to correct for this effect if required. Allow 2 minutes after adjusting any levels before reassessing the monitored gas values. ●● If NOLo alarm is sounding at the same time, there is likely to be a leak in the patient sample path. Check connection of patient sample line connection to the ventilator and NOxBOX®O2 is free from leaks. ●● If PMP/B alarm is sounding at the same time, the low O2 reading may be due to a kink or blockage in the sample path. Resolve this alarm and monitor system www.noxboxltd.com IMPORTANT: NO2 is a highly toxic pulmonary irritant. Remedial action for high NO2 levels should be implemented immediately to protect the patient. ●● Check patient is still breathing. ●● Check inspiratory ventilator flow is present and free from leaks or broken connections. ●● Check NO delivery device flow setting is correct for patient ventilator flow and NO supply cylinder concentration. ●● If appropriate, reduce NO flow from delivery device and allow 2 minutes before reassessing NO2 levels. NOTE: the 2 minutes allows the full impact of any changes to be recorded. ●● Perform a manual zero on the NOxBOX®O2 by pressing the zero button on the right side of the monitor. NOTE: this process takes approximately 2 minutes. ●● If NO2 reading is still high, replace the monitor for another unit to exclude there being a fault with this monitor. ●● If all above steps have not resolved the issue, consider replacing the NO supply cylinder. IMPORTANT: The NO gas flow levels should not deviate substantially (e.g. > +/- 30%) from the guideline settings recommended for the patient vent flow and NO supply cylinder. Rule out a fault with the monitoring equipment before substantially altering the NO flow from 19 English NOxBOX®O2 Operating Manual NOxBOX®O2 Operating Manual English the delivery device. Returns procedure PMP/B If the equipment requires servicing, please contact NOxBOX Ltd’s Customer Repairs department before returning any goods. If the equipment was not purchased directly from NOxBOX Ltd, please contact the local distributor. When flashing, the pump or sample path has a blockage. ●● Check the sample line is not kinked, crushed or trapped. ●● If no visible external blockage present, replace the patient sample line with a new line. ●● If still blocking, replace the patient filter after the water trap ●● Should replacing external components fail to resolve the blockage issue, please refer to your qualified service engineer. Internal filters may need replaced. 2 H2O When flashing, water trap is full. To prevent damage occurring to the NOxBOX®O2 monitor and its sensors, drain the water trap using a suitable syringe (See fig. 6). Drainage syringes are supplied by NOxBOX Ltd or your distributor. 3 BATlow When flashing, battery is low. Plug NOxBOX®O2 unit into an appropriate medical grade power source to resolve. ●● The Customer Repairs department will issue a Returns Number once the monitor serial number and a description of the fault are supplied. ●● State the Returns Number when returning the monitor and ensure that full details, including telephone and fax numbers, are clearly provided. ●● NOxBOX Ltd advises using a courier service when returning monitors. ●● Confirmation will be issued when goods are received. ●● An Engineer’s Report and a quotation for the repair will be sent following investigation. This includes an Authorisation Form. ●● If the monitor is still in warranty, NOxBOX Ltd will repair it and return it with an Engineer’s Report, free of charge. If the monitor is found to simply require calibrating, a fee will be charged. ●● If out of warranty, complete the Authorisation Form included with the quotation to proceed with the repair or calibration. Ensure that an Official Purchase Order Number is included, and return the instrument to NOxBOX Ltd . Contact the Customer Repairs department Specialist if you have any queries. ●● If it is decided not to proceed with the repair, a handling fee will be charged. Ensure that the completed Authorisation Form is returned to NOxBOX Ltd with an Official Purchase Order Number. Figure 6: NOxBOX O2 water trap and syringe ® 20 ●● The equipment will be returned as soon as NOxBOX Ltd has received all relevant paperwork. A carriage fee will be charged if the monitor is out of warranty. English NOxBOX®O2 Operating Manual Spares Part number Description NOXO2-NO Replacement NO sensor for NOxBOX®O2 NOXO2-NO2 Replacement NO2 sensor for NOxBOX®O2 NOXO2-O2 Replacement O2 sensor for NOxBOX®O2 NOXO2-SCS Sample conditioning system for NOxBOX®O2 NOXO2-NAF Nafion tubing for NOxBOX®O2 NOX02WT-COMPLETE Water trap FIX053 Power lead (UK) FIX054 Power lead (EU) NOX-Y-CAL Calibration system (Y-piece and male luer) 034-18-00520-V Calibration gas (25ppm NO in N2) 34-litre disposable cylinder 034-20-01010-V Calibration gas (10ppm NO2 in air) 34-litre disposable cylinder REGSS-1.0-V Calibration regulator, pressure guage and flow outlet SCCG Carry case for cans and regulators NOXKIT-V NOXKIT-NEONATE NOXKIT-CHILD NOXKIT-ADULT A selection of connectors to attach NOxBOX®O2 to a ventilator RECYCLER-V Puncture tool for recycling empty cylinder WIPE-V Instrument Cleansing Wipes NOXO2-FIL Protective Filter NOXO2-INT-FIL Scavenging Filter NOXO2-SL-2.5M 2.5m Sample line NOXO2-PATIENT 2.5m sample line, protective filter, water trap emptying syringe NOXO2-PATIENT-COMP 2.5m sample line, water trap, protective filter, water trap emptying syringe CON139 Luer fitting for NOxBOX®O2 water trap filter CON136 Luer fitting for NOxBOX®O2 water trap sample line NOXO2-BAT Replacement battery unit for NOxBOX®O2 The above spares are available from NOxBOX Ltd, UK. For spares availability in all other countries, contact your local distributor. It is recommended that only NOxBOX Ltd spares are used. Warranty NOxBOX Ltd warrants the NOxBOX®O2 (excluding batteries) to be free of defects in materials and workmanship for a period of twenty four months from the date of shipment. NOxBOX Ltd’s sole obligation under this warranty is limited to repairing or replacing, at its choice, any item covered under this warranty when such an item is returned intact, prepaid, to NOxBOX Ltd or your local representative. Note: Sensors are guaranteed for a period of twelve months from the date of shipment from NOxBOX Ltd. www.noxboxltd.com These warranties are automatically invalidated if the products are repaired, altered, or otherwise tampered with by unauthorised personnel, or have been subject to misuse, neglect or accident. Do not dispose of any electronic equipment or batteries in domestic waste. At the end of the product’s life, contact NOxBOX®O2 or its distributor for disposal instructions. Single use consumables and accessories should be disposed of in line with the local clinical waste guidelines. 21 Notes Notes Station Road, Harrietsham, Maidstone, Kent, ME17 1JA, England Tel: +44 (0)1622 854868 Fax: +44 (0)1622 854860 Email: [email protected] www.noxboxltd.com Issue 10– February 2016 - Part No: LAB463 © NOxBOX Ltd NOxBOX Ltd reserves the right to change or update this literature without prior notice. Registered in England and Wales. Registered No.: 9563860