Care Fusion PrinterNOx User manual

1
PrinterNOx
Operating Manual – English
Gebrauchsanweisung - Deutsch

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Contents
I. Important sa ety in ormation – English ................................ 3
Introduction ..................................................................... 4
Medical Use ...................................................................... 5
NO
2
Production ................................................................. 6
Environmental Sa ety ........................................................ 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
Speci ications ..................................................................32
II. Wichtige Sicherheitshinweise – Deutsch ..............................36
Einleitung........................................................................37
Medizinische Anwendung...................................................38
NO
2
Produktion ................................................................39
Umweltschutz ..................................................................40
Betrieb............................................................................40
1. Messung ...................................................................44
2. Kalibration ................................................................52
3. Alarmeinstellungen ....................................................58
4. Bericht an den Drucker...............................................59

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5. Status ......................................................................59
6. Setup .......................................................................60
7. Durch luss berechnen.................................................61
Batteriebetrieb ................................................................62
Papier einlegen ................................................................63
Batterie wartung ..............................................................64
Reinigung........................................................................66
Wartung..........................................................................67
Symbole .........................................................................67
Elektrische Umgebung ......................................................68
Technische Daten.............................................................68
Customer Contact In ormation ...........................................70

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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 atal even a ter very short
exposures, and prolonged exposure to much lower levels may be
harm ul. All users o nitric oxide must amiliarise themselves with
the appropriate sa ety regulations. When calibrating the PrinterNOx
monitor it is important to ensure that calibration gas is adequately
vented and sa ely exhausted. Nitric oxide reacts with oxygen in air
to orm nitrogen dioxide, an extremely toxic gas with a maximum
allowable industrial ambient level o 5ppm.
The PrinterNOx nitric oxide/nitrogen dioxide monitor has been
designed to the highest standards and incorporates many inbuilt
sel -checks. As with any measurement device, however,
mal unction is possible. When used in the administration o nitric
oxide the PrinterNOx must not, there ore, be incorporated as a
primary part o the NO delivery system, but rather as a sa ety 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 or injury resulting rom mal unction and
ailure to ollow these guidelines. Failure to ollow instructions in the
remainder o this manual may also result in dangerously inaccurate
measurements being obtained.

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Introduction
The PrinterNOx is a combined Nitric Oxide / Nitrogen Dioxide
monitor based on electrochemical uel cells and may be operated
directly rom the mains power or rom the internal rechargeable
NiCad battery pack. Fuel cells work through the reaction o the
target gas with an electrolyte at one electrode and oxygen ( rom
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 or adult respiratory distress
syndrome and pulmonary hypertension on ventilated patients. The
more toxic and non therapeutic by-product, NO
2
, is also monitored.
The NO measurement has a resolution o 0.05 parts per million
(ppm) with a ull scale o 100ppm and the NO
2
measurement has a
resolution o 0.05ppm with a ull scale o 20ppm. The gas to be
monitored is sampled using a constant low (250ml/min), low dead
space, sidestream system. The system includes a water trap, with
integral hydrophobic ilter, and humidity conditioning circuit to
protect the uel cells against extremes o 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 o NO and NO
2
measurements taken are
recorded and stored in the internal battery backed memory and can
be printed or uploaded on the RS232 inter ace or computer storage.
The PrinterNOx includes a number o sa ety eatures and alarms.
These include upper and lower alarms or NO and an upper alarm or
NO
2
. An external alarm cable is available, and when connected to a
NO delivery system, is used to trigger an alarm or initiate a sa e
operating mode i high concentrations o gas are detected. This
concentration is 100ppm or NO, 9ppm NO
2
or alarm level whichever

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is the greater. The low o gas in the sampling line is continuously
monitored and an alarm sounded i the line is occluded or the water
trap is ull. A low battery condition is also alarmed.
The PrinterNOx has been designed with ease o use and reliability as
o oremost importance. To ensure accurate results, however, it is
essential to amiliarise yoursel with the contents o 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 rom a cylinder o 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 sa ety reasons sources with greater than 1000ppm NO should
not be used. Lower concentrations carry less risk either to the
patient in the case o accidental overdose, or to the hospital sta in
the case o leakage. However, i moderately high doses o NO are to
be administered then the decrease in the maximum FiO
2
must be
considered and is given by the relationship:
FiO
2
(max. = (1 - Required NO Conc./Source NO Conc. X
100%
There ore, i 40ppm is required rom a source o 500ppm NO in
nitrogen then the maximum oxygen available would be:
FiO
2
(max. = (1 - 40 / 500 X 100% = 92%

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Methods or therapeutic administration o nitric oxide depend on the
exact type o ventilator and ventilator circuit to be used and have
not yet been standardised. It is there ore the responsibility o the
user to pay due regard to current medical practice when using the
unit to monitor concentrations o inhaled nitric oxide and nitrogen
dioxide.
NO
2
Production
Nitric oxide in the presence o oxygen undergoes the ollowing
chemical reaction to orm nitrogen dioxide, (a more toxic gas than
nitric oxide):
2NO + O
2
→
→→
→ 2NO
2
The rate o conversion is highly dependent on the NO concentration
and this has some important implications or the NO delivery
system.
Firstly, sources o 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 e ectively to rapidly reduce its concentration to the
therapeutic level where NO
2
production will proceed at a much
slower rate.
Environmental Safety
To eliminate environmental pollution with NO and NO
2
the
PrinterNOx is supplied with two NOxSORB chemical scavengers or
removing these gases rom the exhaust. The NOxSORB works by
converting NO to NO
2
, which is then chemically absorbed.

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Connect a NOxSORB to the exhaust o the PrinterNOx, as shown
overlea , orientated such that the arrow is pointing away rom the
instrument. The NOxSORB should be replaced a ter 24 hours or
when the mauve spheres turn dark brown. When re-ordering please
quote 36-SORB100 or a box o 10 o 36-SORB200 or a box o 20.
Environmental pollution with NO and NO
2
may also arise when leaks
are present in the connections to the source o NO.
Operation
Be ore operating the PrinterNOx, ensure that the unit has been ully
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 ilter and
sampling line to the PrinterNOx as shown below:
Sampling
Line
Water
Trap
Micro
Medic al
Water trap
retaining
screws
Exhaust
port
1
Alarm
PAPER
6
42 3 5
9
7
C AN C EL
8
CH A R GIN G
0
EN T ER
PrinterNOx
NOxSORB
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.

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The on/o switch is located at the rear o the unit:
An introductory screen giving the so tware version will be displayed
brie ly:
MICRO MEDICAL
PrinterNOx
V X.XX
During this time the ollowing in ormation 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
AC Adapter
socket
500mA
Power Input
Contrast
Display contrast
adjustment
O
12V 1
On/O
switch
RS232/
Analogue
Output
RS232
socket
External
Alarm
External
alarm
socket

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This in ormation can be checked and the date, time, calibration or
alarm settings may be adjusted prior to per orming a measurement.
(See sections on Setup, Calibration, and Set Alarms)
The calibration due date is set to occur thirty days a ter the last
calibration. However, calibration may be per ormed at any time
be ore this date to improve measurement accuracy. Measurements
can be made a ter 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 o sensitivity is typically
less than 2% per month but could be more i they are exposed to
adverse conditions such as exposure to gas concentrations above
the measurement range or to solvents such as alcohol.
I the calibration due date has passed then the ollowing reminder
will be displayed both a ter 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 irst menu is displayed and allows
selection o several options:

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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 o ,
measurements are not taken, and the gas level alarms are inactive.
I no options are selected then the unit de aults to option 1
“Measurement” a ter 45 seconds. This is done so that the unit
de aults to monitoring gas levels with alarms activated in the event
that the instrument was inadvertently le t on the irst screen or was
switched o and on.
During all other operations, a short warning alarm will occur, a ter
45 seconds o inactivity, to remind the user that measurement mode
is not operational.
1. Measurement
To obtain maximum accuracy rom the measurement care ul
consideration must be given to the NO administration system in use.
Gas measurement with ventilators producing cyclic lows may give
an overestimate or under estimate o the average NO concentration.
This is due to localised variation o NO concentration within the
delivery system. Dependent on the measurement point, there ore,
the sampled average may not correspond to the delivered average.
It is there ore important to ensure that the NO delivery system is
designed to avoid large variations in the level o delivered NO.

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The PrinterNOx utilises a sidestream gas system, which is servo
controlled to sample at a constant rate o 250 ml/min. By supplying
the gas sensors with this constant low, a high degree o accuracy
and sensitivity can be achieved.
To carry out NO / NO
2
measurement, press “1”.
The sampling pump will start and the ollowing screen will be
displayed:
15
5 p
p
4 m
Press ENTER for menu
NO
NO
000
000
2
.
.
The system should now be tested or 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 low rate then the
measurement will cease to be displayed, the pump will continue to
run, and the ollowing message will be displayed:
Gas Line Occluded
or water trap full
Please clear blockage
or empty water trap
and filter.

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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 illing o the water trap.
I 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 o and draw any liquid out o 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 le t-hand side o the NO legend are the upper and lower
alarm levels or NO. On the le t-hand side o the NO
2
legend is the
upper alarm level or NO
2
.
On the bottom line, the rectangle will blink on or o every time a
measurement is updated (every 2.6 seconds) to indicate correct
unctioning o the instrument.
The gas concentrations are given in parts per million (ppm).
I the printer option is turned on (see Setup section), then the
ollowing printout will be obtained during measurement:

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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 or entering the patient name or ID, hospital name, and
technician name are provided.
This is ollowed by the axes or the NO and NO
2
graphs.
These graphs are auto scaled to the current alarm settings.
A section o the graph will be printed once every 32 samples and
includes a time stamp every 15 minutes on the le t-hand side. Each
dot on the graph represents the average o 4 measurements.

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I the measured gas goes outside the range o the alarm settings
then an audible alarm and a red lashing visual alarm will be
generated. In addition, the relevant indicator on the liquid crystal
display will lash. The graph is then replaced by a printout o 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
I the NO measurement exceeds 100ppm or NO
2
exceeds 9ppm then
the external alarm, accessible at the rear o the instrument, is

15
activated. I the NO
2
alarm level is set above 9ppm, then the
external alarm comes into operation at the set level or NO
2
. The
external alarm consists o a pair o 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 sa e
operating mode in systems equipped with this acility.
The display will change to:
.
15
5 p
p
4 m
CUT OUT: PRESS ENTER
987
148
NO
NO
2
.
Measurements will continue but it should be noted that the
measurement range would be limited to just over 100ppm NO and
20ppm NO
2
and that the actual concentrations could be signi icantly
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 o NO, as the sudden cessation o NO can be more
detrimental to the patient than a temporary overdose o NO.
Ideally, the external alarm should be used to switch the delivery
system into a ‘sa e’ operating mode or switch in a backup supply.

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Syringe
adapter
1 5
5
1 0
2 0
Should the water trap ill during the course o the measurement, it
will over low into the integral hydrophobic PTFE ilter, cause an
obstruction, and the ollowing 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 rom
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.

17
Reconnect water trap to the PrinterNOx and secure with the two
retaining screws. I 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 o and draw any liquid out o 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 or a 45-second period by pressing the
CANCEL key.
2. Calibration
I the instrument is in use immediately be ore calibration is
attempted, then the system should be purged with clean air. This
may be done by disconnecting the water trap rom the instrument
and running the instrument in measurement mode or 5 minutes.
To carry out sensor calibration press 2 and the ollowing screen will
be displayed:
Disconnect instrument
from gas sources.
Press ENTER to start
Press CANCEL to abort
The PrinterNOx requires clean air ree rom any NO or NO
2
so that
the sensors can be zeroed.

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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 o both sensors until a stable reading is obtained.
During this time, a line o asterisks appears on the screen to indicate
correct operation.
When zeroing is complete the readings or the NO and NO
2
sensors
are written into the battery backed memory and the display is
changed to:
Calibration
-----------
1 Calibrate NO
2 Calibrate NO2
3 Exit