PrinterNOx
`
`Operating Manual – English
`Gebrauchsanweisung - Deutsch
`
`
`
`
`
`1
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`Ex. 2027-0001
`
`

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`Ex. 2027-0002
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`
`
`
`
`
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`Ex. 2027-0002
`
`

`
`
`
`Contents
`
`I.
`
`Important safety information – English ................................ 3
`Introduction ..................................................................... 4
`Medical Use ...................................................................... 5
`
`NO2 Production ................................................................. 6
`
`Environmental Safety ........................................................ 6
`
`Operation......................................................................... 7
`
` 1. Measurement ............................................................10
`
` 2. Calibration ................................................................17
`
` 3. Set Alarms................................................................23
`
` 4. Report to printer........................................................24
`
` 5. Status ......................................................................24
`
` 6. Setup .......................................................................25
`
` 7. Calculate Flow ...........................................................26
`
` Battery operation.............................................................27
`
`Paper Loading..................................................................28
`
`Battery Maintenance.........................................................29
`
`Cleaning Procedure...........................................................31
`
`Servicing.........................................................................31
`
`Symbols..........................................................................32
`
`Electrical Environment ......................................................32
`
`Specifications ..................................................................32
`
`II. Wichtige Sicherheitshinweise – Deutsch ..............................36
`Einleitung........................................................................37
`Medizinische Anwendung...................................................38
`NO2 Produktion ................................................................39
`Umweltschutz ..................................................................40
`Betrieb............................................................................40
` 1. Messung ...................................................................44
` 2. Kalibration ................................................................52
` 3. Alarmeinstellungen ....................................................58
` 4. Bericht an den Drucker...............................................59
`1
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`
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`
`
`Ex. 2027-0003
`
`

`
`
`
`5. Status .................................................................... ..59
` 5. Status ......................................................................59
`
`6. Setup ..................................................................... ..60
` 6. Setup .......................................................................60
`
`7. Durchfluss berechnen ............................................... ..61
` 7. Durchfluss berechnen .................................................61
`
`Batteriebetrieb .............................................................. . .62
` Batteriebetrieb ................................................................62
`Papier einlegen .............................................................. ..63
`
`Papier einlegen ................................................................63
`Batterie wartung ............................................................ ..64
`
`Batterie wartung ..............................................................64
`
`Reinigung........................................................................66
`Reinigung ...................................................................... ..66
`Wartung ........................................................................ ..67
`
`Wartung..........................................................................67
`Symbole ....................................................................... ..67
`
`Symbole .........................................................................67
`Elektrische Umgebung .................................................... ..68
`
`Elektrische Umgebung ......................................................68
`Technische Daten ........................................................... ..68
`
`Technische Daten .............................................................68
`
`Customer Contact Information ......................................... ..70
`Customer Contact Information ...........................................70
`
`
`
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`
`
`2
`2
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`Ex. 2027-0004
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`Ex. 2027-0004
`
`

`
`
`
`
`
`PrinterNOx
`
`Operating manual
`
`
`I. Important safety information - English
`
`Nitric oxide is a highly toxic gas, exposure to levels as low as 200
`parts per million (ppm) may be fatal even after very short
`exposures, and prolonged exposure to much lower levels may be
`harmful. All users of nitric oxide must familiarise themselves with
`the appropriate safety regulations. When calibrating the PrinterNOx
`monitor it is important to ensure that calibration gas is adequately
`vented and safely exhausted. Nitric oxide reacts with oxygen in air
`to form nitrogen dioxide, an extremely toxic gas with a maximum
`allowable industrial ambient level of 5ppm.
`
`The PrinterNOx nitric oxide/nitrogen dioxide monitor has been
`designed to the highest standards and incorporates many inbuilt
`self-checks. As with any measurement device, however,
`malfunction is possible. When used in the administration of nitric
`oxide the PrinterNOx must not, therefore, be incorporated as a
`primary part of the NO delivery system, but rather as a safety check
`on the delivery system. The delivery system should be constructed
`in such a way as to minimise possible errors. CareFusion Ltd does
`not accept any liability for injury resulting from malfunction and
`failure to follow these guidelines. Failure to follow instructions in the
`remainder of this manual may also result in dangerously inaccurate
`measurements being obtained.
`
`3
`
`Ex. 2027-0005
`
`

`
`
`
`Introduction
`
`The PrinterNOx is a combined Nitric Oxide / Nitrogen Dioxide
`monitor based on electrochemical fuel cells and may be operated
`directly from the mains power or from the internal rechargeable
`NiCad battery pack. Fuel cells work through the reaction of the
`target gas with an electrolyte at one electrode and oxygen (from
`ambient air) at the other. This reaction generates an electrical
`current proportional to gas concentration. In comparison with other
`technologies (such as chemiluminescent detectors) electrochemical
`sensors are compact, inexpensive and much easier to use with zero
`warm up time and simple calibration. The PrinterNOx is designed to
`monitor delivered NO used as a therapy for adult respiratory distress
`syndrome and pulmonary hypertension on ventilated patients. The
`more toxic and non therapeutic by-product, NO2, is also monitored.
`The NO measurement has a resolution of 0.05 parts per million
`(ppm) with a full scale of 100ppm and the NO2 measurement has a
`resolution of 0.05ppm with a full scale of 20ppm. The gas to be
`monitored is sampled using a constant flow (250ml/min), low dead
`space, sidestream system. The system includes a water trap, with
`integral hydrophobic filter, and humidity conditioning circuit to
`protect the fuel cells against extremes of humidity and particulate
`contamination. The measurements are displayed on a large graphic
`liquid crystal display and can be printed as a chart, on the integral
`thermal printer, together with calibration due date and alarm
`settings. The last 24 hours of NO and NO2 measurements taken are
`recorded and stored in the internal battery backed memory and can
`be printed or uploaded on the RS232 interface for computer storage.
`The PrinterNOx includes a number of safety features and alarms.
`These include upper and lower alarms for NO and an upper alarm for
`NO2. An external alarm cable is available, and when connected to a
`NO delivery system, is used to trigger an alarm or initiate a safe
`operating mode if high concentrations of gas are detected. This
`concentration is 100ppm for NO, 9ppm NO2 or alarm level whichever
`4
`
`Ex. 2027-0006
`
`

`
`
`
`is the greater. The flow of gas in the sampling line is continuously
`monitored and an alarm sounded if the line is occluded or the water
`trap is full. A low battery condition is also alarmed.
`
`The PrinterNOx has been designed with ease of use and reliability as
`of foremost importance. To ensure accurate results, however, it is
`essential to familiarise yourself with the contents of this short
`manual.
`
`Medical Use
`
`Nitric oxide (NO) is evolving as a novel therapy used to reduce
`pulmonary arterial pressure and improve gas exchange in paediatric
`and adult intensive care settings. The NO is usually added to the
`ventilator circuit from a cylinder of NO in nitrogen with a
`concentration up to 1000ppm and diluted in the circuit to between 1
`and 40ppm.
`
`Therapeutic concentrations must be well controlled as levels as low
`as 100ppm may cause lung injury.
`
`For safety reasons sources with greater than 1000ppm NO should
`not be used. Lower concentrations carry less risk either to the
`patient in the case of accidental overdose, or to the hospital staff in
`the case of leakage. However, if moderately high doses of NO are to
`be administered then the decrease in the maximum FiO2 must be
`considered and is given by the relationship:
`
`FiO2 (max.) = (1 - Required NO Conc./Source NO Conc.) X
`
`100%
`
`Therefore, if 40ppm is required from a source of 500ppm NO in
`nitrogen then the maximum oxygen available would be:
`
`FiO2 (max.) = (1 - 40 / 500) X 100% = 92%
`
`5
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`Ex. 2027-0007
`
`

`
`
`
`Methods for therapeutic administration of nitric oxide depend on the
`exact type of ventilator and ventilator circuit to be used and have
`not yet been standardised. It is therefore the responsibility of the
`user to pay due regard to current medical practice when using the
`unit to monitor concentrations of inhaled nitric oxide and nitrogen
`dioxide.
`
`NO2 Production
`
`Nitric oxide in the presence of oxygen undergoes the following
`chemical reaction to form nitrogen dioxide, (a more toxic gas than
`nitric oxide):
`
`2NO + O2 →→→→ 2NO2
`
`The rate of conversion is highly dependent on the NO concentration
`and this has some important implications for the NO delivery
`system.
`
`Firstly, sources of NO with excessively high concentrations should be
`avoided.
`
`Secondly, the administered concentration should be kept as low as is
`clinically acceptable.
`
`Finally, the administration system should mix the incoming NO
`quickly and effectively to rapidly reduce its concentration to the
`therapeutic level where NO2 production will proceed at a much
`slower rate.
`
`Environmental Safety
`
`To eliminate environmental pollution with NO and NO2 the
`PrinterNOx is supplied with two NOxSORB chemical scavengers for
`removing these gases from the exhaust. The NOxSORB works by
`converting NO to NO2, which is then chemically absorbed.
`6
`
`Ex. 2027-0008
`
`

`
`
`
`Connect a NOxSORB to the exhaust of the PrinterNOx, as shown
`overleaf, orientated such that the arrow is pointing away from the
`instrument. The NOxSORB should be replaced after 24 hours or
`when the mauve spheres turn dark brown. When re-ordering please
`quote 36-SORB100 for a box of 10 of 36-SORB200 for a box of 20.
`
`Environmental pollution with NO and NO2 may also arise when leaks
`are present in the connections to the source of NO.
`
`Operation
`
`Before operating the PrinterNOx, ensure that the unit has been fully
`charged using the AC adapter supplied. (See Charging Procedure.)
`The PrinterNOx may also be operated with the internal rechargeable
`batteries.
`
`Connect the water trap with integral hydrophobic PTFE filter and
`sampling line to the PrinterNOx as shown below:
`
`
`
`Water trap
`retaining
`screws
`
`Water
`Trap
`
`Sampling
`Line
`
`PrinterNOx
`
`NOxSORB
`
`Micro
`Medical
`
`Alarm
`
`1
`
`6
`
`2
`
`7
`
`3
`
`8
`
`4
`
`9
`
`5
`
`0
`
`PAPER
`
`C AN C EL
`
`C H AR G IN G
`
`EN T ER
`
`Exhaust
`port
`
`
`Switch on the PrinterNOx. Please note that the water trap must
`
`
`
`be used at all times during measurement to avoid
`
`contamination of the fuel cells.
`
`
`
`7
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`Ex. 2027-0009
`
`

`
`
`
`The on/off switch is located at the rear of the unit:
`
`
`
`On/Off
`switch
`
`External
`alarm
`socket
`
`Contrast
`
`O
`
`1
`
`Power Input
` 500mA
` 12V
`
`External
` Alarm
`
` RS232/
`Analogue
` Output
`
`Display contrast
`adjustment
`
`AC Adapter
`socket
`
`RS232
`socket
`
`An introductory screen giving the software version will be displayed
`briefly:
`
`
`
` MICRO MEDICAL
`
` PrinterNOx
`
`
` V X.XX
`
`
`During this time the following information will be printed:
`
`
`
`12/04/95 16:14
`NO calibration due : 01/01/96
`NO2 calibration due : 07/01/96
`NO upper alarm : 15
`NO lower alarm : 5
`NO2 upper alarm : 4
`
`8
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`
`
`Ex. 2027-0010
`
`

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`
`
`This information can be checked and the date, time, calibration or
`alarm settings may be adjusted prior to performing a measurement.
`
`(See sections on Setup, Calibration, and Set Alarms)
`
`The calibration due date is set to occur thirty days after the last
`calibration. However, calibration may be performed at any time
`before this date to improve measurement accuracy. Measurements
`can be made after the calibration due date has passed but
`consideration must be given to the gas sensors which exhibit a slow
`decline in sensitivity over time. This loss of sensitivity is typically
`less than 2% per month but could be more if they are exposed to
`adverse conditions such as exposure to gas concentrations above
`the measurement range or to solvents such as alcohol.
`
`If the calibration due date has passed then the following reminder
`will be displayed both after the introductory screen and when
`commencing measurement:
`
` Calibration due!
`
` NO 12/12/95
` NO2 1/4/96
`
` Press ENTER to
` Continue
`
`
`
`Once ENTER is pressed the first menu is displayed and allows
`selection of several options:
`
`
`
`9
`
`Ex. 2027-0011
`
`

`
`
`
` Select Option
`1 Measurement
`2 Calibration
`3 Set Alarms
`4 Report to printer
`5 Status
`6 Setup
`7 Calculate Flow
`
`
`
`Whilst this display is active the sampling pump is turned off,
`measurements are not taken, and the gas level alarms are inactive.
`
`If no options are selected then the unit defaults to option 1
`“Measurement” after 45 seconds. This is done so that the unit
`defaults to monitoring gas levels with alarms activated in the event
`that the instrument was inadvertently left on the first screen or was
`switched off and on.
`
`During all other operations, a short warning alarm will occur, after
`45 seconds of inactivity, to remind the user that measurement mode
`is not operational.
`
`1. Measurement
`
`To obtain maximum accuracy from the measurement careful
`consideration must be given to the NO administration system in use.
`
`Gas measurement with ventilators producing cyclic flows may give
`an overestimate or under estimate of the average NO concentration.
`
`This is due to localised variation of NO concentration within the
`delivery system. Dependent on the measurement point, therefore,
`the sampled average may not correspond to the delivered average.
`It is therefore important to ensure that the NO delivery system is
`designed to avoid large variations in the level of delivered NO.
`
`10
`
`Ex. 2027-0012
`
`

`
`
`
`The PrinterNOx utilises a sidestream gas system, which is servo
`controlled to sample at a constant rate of 250 ml/min. By supplying
`the gas sensors with this constant flow, a high degree of accuracy
`and sensitivity can be achieved.
`
`To carry out NO / NO2 measurement, press “1”.
`
`The sampling pump will start and the following screen will be
`displayed:
`
`000
`000
`
`..
`
`NO
`NO
`
`15
` 5 p
` p
` 4 m
`2
` Press ENTER for menu
`
`
`
`The system should now be tested for leaks by occluding the
`sampling line. The pump will be heard to rise in pitch as the servo
`system tries to overcome the restriction.
`
`As the pump cannot maintain the required flow rate then the
`measurement will cease to be displayed, the pump will continue to
`run, and the following message will be displayed:
`
` Gas Line Occluded
` or water trap full
` Please clear blockage
` or empty water trap
` and filter.
`
`11
`
`
`
`Ex. 2027-0013
`
`

`
`
`
`When the occlusion is removed, the display will automatically revert
`to the measurement screen. Repeat this procedure by occluding the
`exhaust port.
`
`The sampling line should now be connected to the administered gas,
`normally as close to the patient as possible. The sampling port must
`be positioned in such a way that water cannot enter the tubing,
`causing rapid filling of the water trap.
`
`If the gas line appears to be continuously occluded, remove the
`water trap and empty any water into a suitable container. Ensure
`that there is no occlusion on the exhaust port.
`
`Under exceptional circumstances, water may pass through a
`damaged water trap and obstruct the inlet to the PrinterNOx. In this
`case turn the unit off and draw any liquid out of the inlet with a
`syringe connected directly to the inlet. Replace the water trap with
`a new one, turn the unit on, and return to the measurement screen.
`
`On the left-hand side of the NO legend are the upper and lower
`alarm levels for NO. On the left-hand side of the NO2 legend is the
`upper alarm level for NO2.
`
`On the bottom line, the rectangle will blink on or off every time a
`measurement is updated (every 2.6 seconds) to indicate correct
`functioning of the instrument.
`
`The gas concentrations are given in parts per million (ppm).
`
`If the printer option is turned on (see Setup section), then the
`following printout will be obtained during measurement:
`
`
`
`12
`
`Ex. 2027-0014
`
`

`
`
`
`12/04/95 16:14
`NO calibration due : 01/01/96
`NO2 calibration due : 07/01/96
`NO upper alarm : 15
`NO lower alarm : 5
`NO2 upper alarm : 4
`
`Patient :...............................
`
`Hospital :...............................
`
`Technician :...............................
`
` 5 NO 15 0 NO2 4
`
`1715
`
`1730
`
`
`Spaces for entering the patient name or ID, hospital name, and
`technician name are provided.
`
`
`
`This is followed by the axes for the NO and NO2 graphs.
`
`These graphs are auto scaled to the current alarm settings.
`
`A section of the graph will be printed once every 32 samples and
`includes a time stamp every 15 minutes on the left-hand side. Each
`dot on the graph represents the average of 4 measurements.
`
`13
`
`Ex. 2027-0015
`
`

`
`
`
`If the measured gas goes outside the range of the alarm settings
`then an audible alarm and a red flashing visual alarm will be
`generated. In addition, the relevant indicator on the liquid crystal
`display will flash. The graph is then replaced by a printout of each
`individual measurement together with a time stamp and an alarm
`indicator as shown below:
`
`12/04/95 16:14
`NO calibration due : 01/01/96
`NO2 calibration due : 07/01/96
`NO upper alarm : 15
`NO lower alarm : 5
`NO2 upper alarm : 4
`
`Patient :...............................
`
`Hospital :...............................
`
`Technician :...............................
`
` 5 NO 15 0 NO2 4
`
`1715
`
`1730
`
`1741 Alarm NO = 22.3 NO2 = 1.85
`1741 Alarm NO = 22.4 NO2 = 1.95
`1741 Alarm NO = 23.1 NO2 = 2.10
`1742 Alarm NO = 23.0 NO2 = 1.90
`
`
`If the NO measurement exceeds 100ppm or NO2 exceeds 9ppm then
`the external alarm, accessible at the rear of the instrument, is
`
`14
`
`Ex. 2027-0016
`
`

`
`
`
`activated. If the NO2 alarm level is set above 9ppm, then the
`external alarm comes into operation at the set level for NO2. The
`external alarm consists of a pair of normally closed contacts, which
`are latched open when the above condition occurs. This can be used
`to sound an external alarm or switch a NO delivery system into safe
`operating mode in systems equipped with this facility.
`
`The display will change to:
`
`15
` 5 p
` p
` 4 m
`
`148
`.
`987
`.
`
`NO
`NO2
`
` CUT OUT: PRESS ENTER
`
`
`
`Measurements will continue but it should be noted that the
`measurement range would be limited to just over 100ppm NO and
`20ppm NO2 and that the actual concentrations could be significantly
`higher.
`
`Press enter to clear the external alarm when the reading drops
`below the external alarm levels.
`
`When this condition occurs, the cause should be immediately
`investigated. However, caution should be observed when shutting
`down the supply of NO, as the sudden cessation of NO can be more
`detrimental to the patient than a temporary overdose of NO.
`
`Ideally, the external alarm should be used to switch the delivery
`system into a ‘safe’ operating mode or switch in a backup supply.
`
`15
`
`Ex. 2027-0017
`
`

`
`
`
`Should the water trap fill during the course of the measurement, it
`will overflow into the integral hydrophobic PTFE filter, cause an
`obstruction, and the following message will be displayed:
`
` Gas Line Occluded
` or water trap full
` Please clear blockage
` or empty water trap
` and filter.
`
`
`
`Unscrew the two retaining screws, and remove the water trap from
`the PrinterNOx.
`
`Empty the accumulated water into a suitable container by
`connecting a syringe (20ml minimum size) with the adapter supplied
`and pushing air through the assembly as shown below.
`
`20
`
`15
`
`10
`
`5
`
`Syringe
`adapter
`
`16
`
`
`
`
`
`
`
`Ex. 2027-0018
`
`

`
`
`
`Reconnect water trap to the PrinterNOx and secure with the two
`retaining screws. If the ‘Gas Line Occluded’ message reappears,
`disassemble and replace the water trap with a new one.
`
`Under exceptional circumstances, water may pass through a
`damaged water trap and obstruct the inlet to the PrinterNOx. In this
`case turn the unit off and draw any liquid out of the inlet with a
`syringe connected directly to the inlet. Replace the water trap with
`a new one, turn the unit on, and return to the measurement screen.
`
`The alarm may be muted for a 45-second period by pressing the
`CANCEL key.
`
`2. Calibration
`
`If the instrument is in use immediately before calibration is
`attempted, then the system should be purged with clean air. This
`may be done by disconnecting the water trap from the instrument
`and running the instrument in measurement mode for 5 minutes.
`
`To carry out sensor calibration press 2 and the following screen will
`be displayed:
`
`Disconnect instrument
` from gas sources.
`
`Press ENTER to start
`Press CANCEL to abort
`
`The PrinterNOx requires clean air free from any NO or NO2 so that
`the sensors can be zeroed.
`
`
`
`17
`
`Ex. 2027-0019
`
`

`
`
`
`With the water trap disconnected, press enter and the display will
`change to:
`
`
`
` Zeroing
`
`
`
` *..............
`
`Press CANCEL to abort
`
`The sampling pump will start and the PrinterNOx will monitor the
`output of both sensors until a stable reading is obtained.
`
`During this time, a line of asterisks appears on the screen to indicate
`correct operation.
`
`When zeroing is complete the readings for the NO and NO2 sensors
`are written into the battery backed memory and the display is
`changed to:
`
` Calibration
` -----------
` 1 Calibrate NO
` 2 Calibrate NO2
` 3 Exit
`
`
`
`18
`
`
`
`Ex. 2027-0020
`
`

`
`
`
`Press “1” to calibrate NO and the display will change to:
`
`Enter NO calibration
`gas concentration:
`
` 00.0 ppm
`
`
`
`
`Enter the required gas concentration using the DELETE key to
`correct any mistakes and press ENTER.
`
`The display will change to:
`
`Pass calibration gas
` through instrument
`
`Press ENTER to start
`Press CANCEL to abort
`
`
`
`CareFusion can supply calibration gas (25ppm NO in nitrogen and
`10ppm NO2 in air) complete with a control valve for simple and
`economic user calibration.
`
`The gas is supplied in convenient, disposable, aluminium canisters
`containing 58 litres of gas (Cat No 36-GAS100 for 25ppm NO in
`nitrogen and 36-GAS200 for 10ppm NO2 in air). A flow regulator
`pre-set to deliver 500ml/min is available separately, Cat No 36-
`GAS500. With careful use, approximately 45 calibrations can be
`obtained from each canister.
`
`19
`
`Ex. 2027-0021
`
`

`
`
`
`Screw the control valve on to the canister and connect to the
`PrinterNOx with the water trap connected as shown below:
`
`Pre-set
`
`Flow
`
`Regulator
`(500ml/min)
`
`Pressure
`Guage
`0
`psi 1000
`USE NO OIL
`
`One Way
`Relief Valve
`
`Control
`Valve
`
`25 ppm
`Nitric Oxide
`in Nitrogen
`
` OR
` 10 ppm
`Nitrogen Dioxide
`in air
`
`PrinterNOx
`
`Medical
`
`Micro
`
`1
`6
`PAPER
`
`2
`7
`CANCEL
`
`3
`4
`8
`9
`CHARGIN G
`
`5
`0
`ENTER
`
`Alarm
`
`Slowly turn the control knob fully anti-clockwise. This will then
`supply a flow of approximately 500ml/min. As the PrinterNOx
`samples at a rate of 250ml/min then 250ml/min will be vented
`through the one way valve.
`
`
`
`20
`
`
`
`Ex. 2027-0022
`
`

`
`
`
`Press ENTER on the keypad and the display will change to:
`
` Calibrating NO
`
` *.............
`
`Press CANCEL to abort
`
`
`
`The sampling pump will start and the PrinterNOx will monitor the
`output of the NO sensor until a stable reading is obtained. When
`stability has been achieved the calibration factor, time and date are
`written into the battery backed memory and the display returns to
`the previous screen. Remove the control valve by turning anti-
`clockwise to stop the gas flow. The NO2 sensor can now be
`calibrated using the same procedure if required.
`
`Within the lifetime of the sensors, zero drift of more than 10ppm
`(1ppm for NO2) or a calibration drift of more than 40% implies
`abnormal ageing of the electrochemical cell. If these errors are
`detected during the zeroing procedure or the calibration adjustment
`then the following will be displayed:
`
`------- ERROR -------
`Reading out of range:
`Check gas supply and
` try again.
` Refer to manual if
` error recurs.
`
` Press any key
`
`
`
`
`
`21
`
`Ex. 2027-0023
`
`

`
`
`
`The most likely reason for this message is an operational error in the
`calibration procedure rather than a faulty sensor.
`
`If this occurs during zeroing repeat the procedure and check that
`there is no nitric oxide, or nitrogen dioxide contamination, and that
`the water trap has been removed.
`
`If the calibration error message appears during sensitivity
`adjustment, repeat the calibration procedure and check:
`
`1. Is calibration gas within its warranty period?
`
`2. Has correct gas concentration been entered?
`
`3. Have the correct connections been made with no leaks?
`
`4. Is there sufficient calibration gas flow?
`
`5. Is there any reaction between nitric oxide and the
`connectors used?
`
`6. Are there any contaminants between nitric oxide supply and
`sensor?
`
`Nitric oxide is a very reactive gas and it is difficult to maintain a
`stable concentration within a cylinder. It is therefore advisable to
`have some independent means of checking the calibration gas used.
`
`After calibration is complete, selecting option “3 Exit” will return the
`display to the main menu screen.
`
`22
`
`
`
`Ex. 2027-0024
`
`

`
`
`
`3. Set Alarms
`
`Selecting option three will allow the NO and NO2 alarm levels to be
`set individually from the following menu:
`
` Set Alarms
`
` 1 Upper NO : 20
` 2 Lower NO : 5
` 3 Upper NO2 : 4
` 4 Exit
`
`The current alarm levels are displayed for reference and, for
`example, the upper alarm level for NO may be altered by selecting
`option 1 when the following screen will be displayed:
`
`
`
` Enter new alarm
` level :
`
` Upper NO :
`
`
`
`Type in the required alarm level and press ENTER.
`
`The lower NO and NO2 alarm levels are set with the same procedure
`with option 2 and 3 respectively.
`
`The valid range of entry is 0 to 99 for the NO upper and lower
`alarms and the upper alarm must be set higher than the lower
`alarm.
`
`23
`
`Ex. 2027-0025
`
`

`
`
`
`For NO2, the valid range of entry is zero to 19
`
`When the required alarms have been set, then selecting option 4 will
`return to the main menu.
`
`4. Report to printer (RS232)
`
`The last 24 hours of measurements are stored in battery backed
`memory and may be either printed or directed to the RS232 port at
`the rear of the instrument. The choice of recovery method depends
`upon whether the printer or RS232 port is currently active (see
`Setup).
`
`If the RS232 port is active then the data, in ASCII format, may be
`uploaded to a PC running standard communication software. A
`serial cable, Cat No 36-CAB1108, is available from CareFusion.
`
`Note: Please ensure that all PC’s and peripheral equipment comply
`to EN60950 ‘Safety of Information Technology Equipment’ and keep
`them out of reach of the patient when connected to the PrinterNOx.
`
`5. Status
`
`This option allows the current configuration and sensor information
`to be displayed.
`
`24
`
`
`
`Ex. 2027-0026
`
`

`
`
`6. Setup
`
`Selecting this menu item allows various options to be set and
`displays the screen:
`
` SET UP
` 1 Clear memory
` 2 Set date/time
` 3 Toggle output:
` *printer RS232
` 4 Toggle date format
` *DD/MM MM/DD
` 5 Exit
`
`
`
`The first option clears the stored 24 hours data from the memory.
`This is done when the currently stored data is of no interest or has
`previously been accessed so that future access of required data will
`be quicker.
`
`The second option is used to change the date and time stored in the
`real time clock.
`
`“Toggle output” is used to select whether data is sent to the printer
`or the RS232 port at the rear of the instrument. An asterisk appears
`against the selected output device. The initial few lines of
`calibration and alarm information is always printed regardless
`whether the printer is selected.
`
`The date format can be changed using option 4.
`
`Option 5 returns the display to the main menu screen.
`
`25
`
`
`
`Ex. 2027-0027
`
`

`
`
`7. Calculate Flow
`
`This facility is used to calculate the required NO flow to achieve the
`required therapeutic concentration for ventilators which employ a
`constant bias flow arrangement. When selected the following screen
`is displayed:
`
` Enter ventilator
` bias flow:
`
` L/min
`
`The valid range for the bias flow is 1-99 and once entered the
`display changes to:
`
`
`
` Enter NO gas
` concentration in
` bottle:
`
` ppm
`
`Gas concentrations of between 50 and 1000ppm may be entered.
`
`
`
`26
`
`
`
`Ex. 2027-0028
`
`

`
`
`
`Following this, the required NO concentration in the range 1 to 100
`should be entered:
`
` Enter required NO
` gas concentration
` to patient:
`
` ppm
`
`When all the data is entered the required NO flow and the maximum
`FiO2 is calculated and displayed on the following screen:
`
`
`
`Bias flow 70 L/m
`Bottle conc 650 ppm
`Patient conc 20 ppm
`
`Req NO flow 2.22 L/m
`Maximum FiO2 96.9 %
`
`Press key to continue
`
`
`
`Battery operation
`
`During patient transportation or mains power failure, the PrinterNOx
`may be powered from the internal rechargeable batteries for
`approximately 2 hours.
`
`27
`
`
`
`Ex. 2027-0029
`
`

`
`
`
`When the batteries are low the alarm will sound continuously and
`the following screen will be displayed:
`
` Battery low!
`
`Please connect charger
`and wait.
`
`
`
`
`Paper Loading
`
`The PrinterNOx requires thermal paper (Part Number 36-PSA1600 -
`Pack of 5 rolls) for the printer.
`
`A warning line appears when 30cm of the paper roll remains. A new
`roll should be loaded when this mark becomes visible.
`
`To load paper:
`
`a. Switch on the PrinterNOx.
`b. Cut the leading edge of the paper so that it is parallel to the
`roll shaft.
`c. Remove the paper cover.
`d. Align the paper so that it is straight when it is inserted into
`the paper inlet.
`e. Press the “PAPER” key to feed the paper until the leading
`edge of the paper passes the paper cutter.
`f. Replace paper cover.
`
`28
`
`
`
`Ex. 2027-0030
`
`

`
`
`
`Make sure that the specified paper (Part Number 36-PSA1600) is
`used as excessive wear on the thermal print head may occur if paper
`from other manufacturers is used. The following precautions should
`be observed when storing or handling the thermal paper rolls:
`
`• Do allow the printer to run without paper loaded.
`• Do not store paper rolls in places exposed to direct sunlight.
`• Do not use pastes containing organic solvents such as
`alcohol, esters or ketones.
`• Do not allow the paper t